Page last updated: 2024-10-29

ketamine and Dizzyness

ketamine has been researched along with Dizzyness in 11 studies

Ketamine: A cyclohexanone derivative used for induction of anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE) and may interact with sigma receptors.
ketamine : A member of the class of cyclohexanones in which one of the hydrogens at position 2 is substituted by a 2-chlorophenyl group, while the other is substituted by a methylamino group.

Research Excerpts

ExcerptRelevanceReference
" This study was conducted to compare the analgesic efficacy of morphine plus ketamine (MK) versus morphine plus placebo (MP) in patients with acute renal colic."9.30Comparing the analgesic efficacy of morphine plus ketamine versus morphine plus placebo in patients with acute renal colic: A double-blinded randomized controlled trial. ( Bozorgi, F; Erfanian Irankar, S; Hosseini, SA; Hosseininejad, SM; Jahanian, F; Moosazadeh, M; Shahbakhti, N, 2019)
"Esketamine is a promising drug which can induce antidepressant effects in Major Depression Disorder (MDD)."9.22Adverse Effects of Esketamine for the Treatment of Major Depression Disorder: Findings from Randomized Controlled Trials. ( Chen, G; Li, X; Wang, J; Wang, T; Xu, X; Xu, Z; Yang, S; Zhou, X, 2022)
"A low-dose ketamine infusion protocol provided significant pain relief with mostly mild side effects and no severe adverse events."7.81Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain. ( Ahern, TL; Frazee, BW; Herring, AA; Miller, S, 2015)
" This study was conducted to compare the analgesic efficacy of morphine plus ketamine (MK) versus morphine plus placebo (MP) in patients with acute renal colic."5.30Comparing the analgesic efficacy of morphine plus ketamine versus morphine plus placebo in patients with acute renal colic: A double-blinded randomized controlled trial. ( Bozorgi, F; Erfanian Irankar, S; Hosseini, SA; Hosseininejad, SM; Jahanian, F; Moosazadeh, M; Shahbakhti, N, 2019)
"Esketamine is a promising drug which can induce antidepressant effects in Major Depression Disorder (MDD)."5.22Adverse Effects of Esketamine for the Treatment of Major Depression Disorder: Findings from Randomized Controlled Trials. ( Chen, G; Li, X; Wang, J; Wang, T; Xu, X; Xu, Z; Yang, S; Zhou, X, 2022)
" morphine and placebo, chiefly dizziness, poor concentration, and feelings of happiness."5.20Comparison of the effects of ketamine and morphine on performance of representative military tasks. ( Athy, JR; Gaydos, SJ; Grandizio, CM; Kelley, AM; Walters, PL, 2015)
" Nitrous oxide (N(2)O) has the advantages of being a sedative agent that does not require a painful injection and that offers shallower levels of sedation and a rapid recovery of mental state."5.16A randomized comparison of nitrous oxide versus intravenous ketamine for laceration repair in children. ( Eun, SC; Heo, CY; Jo, YH; Kim, K; Kim, SH; Kim, TY; Lee, JH; Rhee, JE, 2012)
"A low-dose ketamine infusion protocol provided significant pain relief with mostly mild side effects and no severe adverse events."3.81Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain. ( Ahern, TL; Frazee, BW; Herring, AA; Miller, S, 2015)
"Esketamine was associated with significant cognitive performance impairment at 40 min postdose for all five Cogstate® tests (Detection p = 0."2.87Effect of intranasal esketamine on cognitive functioning in healthy participants: a randomized, double-blind, placebo-controlled study. ( Drevets, WC; Fedgchin, M; Lim, KS; Morrison, RL; Singh, J; van der Ark, P; Van Gerven, J; Wajs, E; Xi, L; Zannikos, P; Zuiker, R, 2018)
" The aim of this prospective observational audit was to evaluate our practice and report the occurrence of adverse events and behavioral reactions related to the use of ketamine, propofol, and midazolam combinations."1.35Adverse events and behavioral reactions related to ketamine based anesthesia for anorectal manometry in children. ( Dalal, PG; Seth, N; Somerville, N; Taylor, D, 2008)

Research

Studies (11)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's3 (27.27)29.6817
2010's5 (45.45)24.3611
2020's3 (27.27)2.80

Authors

AuthorsStudies
Williamson, DJ1
Gogate, JP1
Kern Sliwa, JK1
Manera, LS1
Preskorn, SH1
Winokur, A1
Starr, HL1
Daly, EJ1
Min, M1
Du, C1
Chen, X1
Xin, W1
Yang, S1
Wang, J1
Li, X1
Wang, T1
Xu, Z1
Xu, X1
Zhou, X1
Chen, G1
Morrison, RL1
Fedgchin, M1
Singh, J1
Van Gerven, J1
Zuiker, R1
Lim, KS1
van der Ark, P1
Wajs, E1
Xi, L1
Zannikos, P1
Drevets, WC1
Hosseininejad, SM1
Jahanian, F1
Erfanian Irankar, S1
Moosazadeh, M1
Hosseini, SA1
Shahbakhti, N1
Bozorgi, F1
Gaydos, SJ1
Kelley, AM1
Grandizio, CM1
Athy, JR1
Walters, PL1
Ahern, TL1
Herring, AA1
Miller, S1
Frazee, BW1
Dilli, D1
Dallar, Y1
Sorgui, NH1
Lee, JH1
Kim, K1
Kim, TY1
Jo, YH1
Kim, SH1
Rhee, JE1
Heo, CY1
Eun, SC1
Cherng, CH1
Wong, CS1
Dalal, PG1
Taylor, D1
Somerville, N1
Seth, N1

Clinical Trials (8)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression[NCT02497287]Phase 3802 participants (Actual)Interventional2015-09-30Completed
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression[NCT02493868]Phase 3719 participants (Actual)Interventional2015-10-01Completed
A Randomized, Double-blind, Placebo-controlled, 2-period Crossover Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects[NCT02094378]Phase 124 participants (Actual)Interventional2014-06-30Completed
A Combination Study With Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain in the Emergency Department[NCT03959852]Phase 46 participants (Actual)Interventional2019-11-18Terminated (stopped due to Residency completed.)
Comparison of Intravenous Push Dose of Low Dose Ketamine to Short Infusion of Low Dose Ketamine for Treatment of Moderate to Severe Pain in the Emergency Department: A Prospective, Randomized, Double-Blind Study[NCT02363270]48 participants (Actual)Interventional2015-04-01Completed
Intraoperative Low-dose Ketamine Infusion as the Main Analgesic in Burn Patients[NCT03049930]Phase 446 participants (Anticipated)Interventional2018-02-27Recruiting
Low-Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department Geriatric Population: A Prospective, Randomized, Double-Blind Study.[NCT02673372]Phase 460 participants (Actual)Interventional2016-04-30Completed
Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.[NCT00834730]Phase 432 participants (Actual)Interventional2009-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranges from 2 to 3.3 log 10 milliseconds (msec). Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant-0.0028

Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranges from 0 to 999 number of errors. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber of Errors (Mean)
Intranasal Esketamine + Oral Antidepressant6.9

Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranges from 2 to 3.3 log 10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant-0.0083

Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score

The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranges from 2 to 3.54 log10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant0.0177

Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionArcsine ([sqrt] of proportion of [CR]) (Mean)
Intranasal Esketamine + Oral Antidepressant0.0502

Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall

HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber correct (Mean)
Intranasal Esketamine + Oral Antidepressant0.8

Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled

HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber of words recalled (Mean)
Intranasal Esketamine + Oral Antidepressant0.3

Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index

HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionNumber of words (Mean)
Intranasal Esketamine + Oral Antidepressant0.5

Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall

Hopkins Verbal Learning Test (HVLT) measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber correct (Mean)
Intranasal Esketamine + Oral Antidepressant2.8

Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase

"SDS was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, (3) family life/home responsibilities using a 0 to 10 rating scale. Score for the first three items are summed to create a total score of 0 to 30, higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-9.3

Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase

"SDS was a participant-reported outcome measure and was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0 to 10 rating scale. The score for the first three items are summed to create a total score of 0 to 30 where a higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-1.6

Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase

"The CGI-S measures the severity of the participant's illness that include knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant0.0

Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase

"CGI-S measures severity of participant's illness that include knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluates severity of psychopathology on a scale range from 0 - 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant-2.0

Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.190

Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.009

Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS

EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant17.0

Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS

EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant1.6

Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-15.3

Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.7

Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase

"GAD-7 is brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.2

Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase

"GAD-7 is brief, validated 7-item self-reported assessment of overall anxiety. Participant's responded to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of GAD-7 is categorized as: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method, last post baseline observation during the phase was carried forward as Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-5.9

Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase

"MADRS measure depression severity, detects changes due to AD treatment. It evaluates 10 items: apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.3

Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase

"MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method, last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-16.4

Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase

"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnit on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-8.9

Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase

"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.2

Percentage of Participants With an Increase Score From Predose at Any Time in CADSS Total Score During OP/MA Phase

"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition." (NCT02497287)
Timeframe: Predose, up to 1.5 hours postdose (up to end of OP/MA phase [Week 52])

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant86.1

Percentage of Participants With an Increase Score From Predose at Any Time in Clinician-Administered Dissociative States Scale (CADSS) Total Score During IND Phase

"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition." (NCT02497287)
Timeframe: Predose, up to 1.5 hours postdose (up to end of IND phase [Week 4])

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant92.0

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an event that was new in onset or increased in severity following treatment initiation. (NCT02497287)
Timeframe: Up to End of Follow up Phase (Week 56)

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant90.1

Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders

"Percentage of participants with cystitis, urinary tract infections, renal and urinary tract symptoms, renal and urinary disorders were evaluated. Cystitis and urinary tract infections are selected MedDRA preferred terms, renal and urinary tract symptoms refers to any preferred term (PT) in the group of selected PTs; and renal and urinary disorders refers to a MedDRA System Organ Class (SOC)." (NCT02497287)
Timeframe: Up to End of Follow up Phase (Week 56)

InterventionPercentage of participants (Number)
CystitisUrinary tract infectionsRenal and urinary disordersRenal and urinary tract symptoms
Intranasal Esketamine + Oral Antidepressant0.68.110.517.0

Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase

"Remission is defined as MADRS total score less than or equal to (<=) 12. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Days 8, 15, 22 and Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)

InterventionPercentage of participants (Number)
Day 8Day 15Day 22End point
Intranasal Esketamine + Oral Antidepressant7.315.627.247.2

Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase

"Remission is defined as PHQ-9 total score <= 4. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Day 15 and Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionPercentage of participants (Number)
Day 15Endpoint
Intranasal Esketamine + Oral Antidepressant12.726.9

Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase

"Response is defined as greater than or equal to (>=) 50 % reduction from baseline in the MADRS total score. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Days 8, 15, 22 and Endpoint (last post-baseline assessment during 4 weeks of IND phase)

InterventionPercentage of participants (Number)
Day 8Day 15Day 22End point
Intranasal Esketamine + Oral Antidepressant11.625.042.878.4

Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase

"Response is defined as >= 50 % reduction from baseline (IND phase) in PHQ-9 total score. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Day 15 and Endpoint (last post-baseline assessment value during 4 Week IND phase)

InterventionPercentage of participants (Number)
Day 15End point
Intranasal Esketamine + Oral Antidepressant37.262.0

Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases

Percentage of participants with treatment-emergent acute hypertension (Systolic Blood Pressure >=180 millimeters of mercury [mm Hg] or Diastolic Blood Pressure >= 110 mm Hg) during IND and OP/MA Phases were evaluated. (NCT02497287)
Timeframe: Up to End of OP/MA phase (Week 52)

InterventionPercentage of participants (Number)
Systolic BP >=180Diastolic BP >=110Acute hypertension
Intranasal Esketamine + Oral Antidepressant2.22.44.1

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-10.4
Oral AD+ Intranasal Placebo-16.1

Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-1.3
Oral AD+ Intranasal Placebo-13.8

Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)

"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.067
Oral AD+ Intranasal Placebo-0.096

Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.023
Oral AD+ Intranasal Placebo-0.073

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo10.9

Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.0
Oral AD+ Intranasal Placebo8.4

Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo4.0

Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.4
Oral AD+ Intranasal Placebo2.6

Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (last observation carried forward [LOCF] data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo12.5

Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.4
Oral AD+ Intranasal Placebo11.4

Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.3
Oral AD+ Intranasal Placebo5.9

Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.7
Oral AD+ Intranasal Placebo4.7

Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.7
Oral AD+ Intranasal Placebo7.2

Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo6.8

Time to Relapse in Participants With Stable Remission (Maintenance Phase)

Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable remission: MADRS total score less than or equal to (<=) 12 for at least 3 of last 4 weeks of OP phase, with 1 excursion total score greater than (>) 12 or one missing assessment at OP week 13 or 14. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)

InterventionDays (Median)
Intranasal Esketamine + Oral ADNA
Oral AD+ Intranasal Placebo273.0

Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

Relapse is defined as any of following: MADRS total score >= 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable response is defined as >= 50 percent (%) reduction in MADRS total score from baseline (Day 1 of induction phase, prior to first intranasal dose) in each of the last 2 weeks of the OP phase, but without meeting criteria for stable remission. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)

InterventionDays (Median)
Intranasal Esketamine + Oral AD635.0
Oral AD+ Intranasal Placebo88.0

Overall Rate of Feeling Unreality

Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA) (NCT02363270)
Timeframe: 30 minutes

InterventionParticipants (Count of Participants)
IV Push Group22
IV Drip Group13

Reduction of Pain Score at 30 Minutes

The primary outcome will be the comparative reduction of NRS pain scores between the 2 groups at 30 minutes. The NRS Pain scale ranges from 0 to 10 (0 being no pain at all to 10 being very severe pain; 5 is moderate pain) (NCT02673372)
Timeframe: 30 minutes

Interventionscore on a scale (Mean)
Morphine Group4.4
Ketamine Group4.2

Reviews

1 review available for ketamine and Dizzyness

ArticleYear
Adverse Effects of Esketamine for the Treatment of Major Depression Disorder: Findings from Randomized Controlled Trials.
    The Psychiatric quarterly, 2022, Volume: 93, Issue:1

    Topics: Depression; Dizziness; Humans; Hypesthesia; Ketamine; Nausea; Paresthesia; Randomized Controlled Tri

2022

Trials

6 trials available for ketamine and Dizzyness

ArticleYear
Effect of subanesthetic dose of esketamine on postoperative rehabilitation in elderly patients undergoing hip arthroplasty.
    Journal of orthopaedic surgery and research, 2023, Apr-03, Volume: 18, Issue:1

    Topics: Aged; Analgesia, Patient-Controlled; Arthroplasty, Replacement, Hip; Dizziness; Femoral Neck Fractur

2023
Effect of intranasal esketamine on cognitive functioning in healthy participants: a randomized, double-blind, placebo-controlled study.
    Psychopharmacology, 2018, Volume: 235, Issue:4

    Topics: Administration, Intranasal; Adult; Cognition; Cognitive Dysfunction; Cross-Over Studies; Dizziness;

2018
Comparing the analgesic efficacy of morphine plus ketamine versus morphine plus placebo in patients with acute renal colic: A double-blinded randomized controlled trial.
    The American journal of emergency medicine, 2019, Volume: 37, Issue:6

    Topics: Acute Disease; Adult; Analgesics; Dizziness; Double-Blind Method; Drug Therapy, Combination; Emergen

2019
Comparison of the effects of ketamine and morphine on performance of representative military tasks.
    The Journal of emergency medicine, 2015, Volume: 48, Issue:3

    Topics: Adult; Analgesics; Analgesics, Opioid; Cross-Over Studies; Dizziness; Double-Blind Method; Female; H

2015
Intravenous ketamine plus midazolam vs. intravenous ketamine for sedation in lumbar puncture: a randomized controlled trial.
    Indian pediatrics, 2008, Volume: 45, Issue:11

    Topics: Adolescent; Anesthetics, Dissociative; Anesthetics, Intravenous; Child; Confidence Intervals; Dizzin

2008
A randomized comparison of nitrous oxide versus intravenous ketamine for laceration repair in children.
    Pediatric emergency care, 2012, Volume: 28, Issue:12

    Topics: Administration, Inhalation; Analgesics, Non-Narcotic; Anesthesia Recovery Period; Anesthesia, Inhala

2012

Other Studies

4 other studies available for ketamine and Dizzyness

ArticleYear
Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression.
    The Journal of clinical psychiatry, 2022, 09-19, Volume: 83, Issue:6

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Major;

2022
Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression.
    The Journal of clinical psychiatry, 2022, 09-19, Volume: 83, Issue:6

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Major;

2022
Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression.
    The Journal of clinical psychiatry, 2022, 09-19, Volume: 83, Issue:6

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Major;

2022
Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression.
    The Journal of clinical psychiatry, 2022, 09-19, Volume: 83, Issue:6

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Major;

2022
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
    Pain medicine (Malden, Mass.), 2015, Volume: 16, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship,

2015
Ketamine-induced emergence reactions after desflurane anaesthesia.
    European journal of anaesthesiology, 2007, Volume: 24, Issue:2

    Topics: Analgesics; Anesthesia; Anesthesia Recovery Period; Anesthetics, Inhalation; Desflurane; Dizziness;

2007
Adverse events and behavioral reactions related to ketamine based anesthesia for anorectal manometry in children.
    Paediatric anaesthesia, 2008, Volume: 18, Issue:3

    Topics: Anal Canal; Anesthesia Recovery Period; Anesthesia, Intravenous; Anesthetics, Combined; Anesthetics,

2008