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.
Excerpt | Relevance | Reference |
---|---|---|
" 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." | 9.30 | Comparing 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)." | 9.22 | Adverse 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." | 7.81 | Low-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." | 5.30 | Comparing 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)." | 5.22 | Adverse 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." | 5.20 | Comparison 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." | 5.16 | A 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." | 3.81 | Low-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." | 2.87 | Effect 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." | 1.35 | Adverse events and behavioral reactions related to ketamine based anesthesia for anorectal manometry in children. ( Dalal, PG; Seth, N; Somerville, N; Taylor, D, 2008) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 3 (27.27) | 29.6817 |
2010's | 5 (45.45) | 24.3611 |
2020's | 3 (27.27) | 2.80 |
Authors | Studies |
---|---|
Williamson, DJ | 1 |
Gogate, JP | 1 |
Kern Sliwa, JK | 1 |
Manera, LS | 1 |
Preskorn, SH | 1 |
Winokur, A | 1 |
Starr, HL | 1 |
Daly, EJ | 1 |
Min, M | 1 |
Du, C | 1 |
Chen, X | 1 |
Xin, W | 1 |
Yang, S | 1 |
Wang, J | 1 |
Li, X | 1 |
Wang, T | 1 |
Xu, Z | 1 |
Xu, X | 1 |
Zhou, X | 1 |
Chen, G | 1 |
Morrison, RL | 1 |
Fedgchin, M | 1 |
Singh, J | 1 |
Van Gerven, J | 1 |
Zuiker, R | 1 |
Lim, KS | 1 |
van der Ark, P | 1 |
Wajs, E | 1 |
Xi, L | 1 |
Zannikos, P | 1 |
Drevets, WC | 1 |
Hosseininejad, SM | 1 |
Jahanian, F | 1 |
Erfanian Irankar, S | 1 |
Moosazadeh, M | 1 |
Hosseini, SA | 1 |
Shahbakhti, N | 1 |
Bozorgi, F | 1 |
Gaydos, SJ | 1 |
Kelley, AM | 1 |
Grandizio, CM | 1 |
Athy, JR | 1 |
Walters, PL | 1 |
Ahern, TL | 1 |
Herring, AA | 1 |
Miller, S | 1 |
Frazee, BW | 1 |
Dilli, D | 1 |
Dallar, Y | 1 |
Sorgui, NH | 1 |
Lee, JH | 1 |
Kim, K | 1 |
Kim, TY | 1 |
Jo, YH | 1 |
Kim, SH | 1 |
Rhee, JE | 1 |
Heo, CY | 1 |
Eun, SC | 1 |
Cherng, CH | 1 |
Wong, CS | 1 |
Dalal, PG | 1 |
Taylor, D | 1 |
Somerville, N | 1 |
Seth, N | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression[NCT02497287] | Phase 3 | 802 participants (Actual) | Interventional | 2015-09-30 | Completed | ||
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression[NCT02493868] | Phase 3 | 719 participants (Actual) | Interventional | 2015-10-01 | Completed | ||
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 1 | 24 participants (Actual) | Interventional | 2014-06-30 | Completed | ||
A Combination Study With Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain in the Emergency Department[NCT03959852] | Phase 4 | 6 participants (Actual) | Interventional | 2019-11-18 | Terminated (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) | Interventional | 2015-04-01 | Completed | |||
Intraoperative Low-dose Ketamine Infusion as the Main Analgesic in Burn Patients[NCT03049930] | Phase 4 | 46 participants (Anticipated) | Interventional | 2018-02-27 | Recruiting | ||
Low-Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department Geriatric Population: A Prospective, Randomized, Double-Blind Study.[NCT02673372] | Phase 4 | 60 participants (Actual) | Interventional | 2016-04-30 | Completed | ||
Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.[NCT00834730] | Phase 4 | 32 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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)
Intervention | log10 msec (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.0028 |
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)
Intervention | Number of Errors (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 6.9 |
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)
Intervention | log10 msec (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.0083 |
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)
Intervention | log10 msec (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.0177 |
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)
Intervention | Arcsine ([sqrt] of proportion of [CR]) (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.0502 |
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)
Intervention | Number correct (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.8 |
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)
Intervention | Number of words recalled (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.3 |
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)
Intervention | Number of words (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.5 |
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)
Intervention | Number correct (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 2.8 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -9.3 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -1.6 |
"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)
Intervention | Units on a Scale (Median) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.0 |
"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)
Intervention | Units on a Scale (Median) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -2.0 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.190 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.009 |
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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 17.0 |
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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 1.6 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -15.3 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.7 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.2 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -5.9 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.3 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -16.4 |
"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. 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)
Intervention | Unit on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -8.9 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.2 |
"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])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 86.1 |
"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])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 92.0 |
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)
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 90.1 |
"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)
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Cystitis | Urinary tract infections | Renal and urinary disorders | Renal and urinary tract symptoms | |
Intranasal Esketamine + Oral Antidepressant | 0.6 | 8.1 | 10.5 | 17.0 |
"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)
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Day 8 | Day 15 | Day 22 | End point | |
Intranasal Esketamine + Oral Antidepressant | 7.3 | 15.6 | 27.2 | 47.2 |
"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)
Intervention | Percentage of participants (Number) | |
---|---|---|
Day 15 | Endpoint | |
Intranasal Esketamine + Oral Antidepressant | 12.7 | 26.9 |
"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)
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Day 8 | Day 15 | Day 22 | End point | |
Intranasal Esketamine + Oral Antidepressant | 11.6 | 25.0 | 42.8 | 78.4 |
"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)
Intervention | Percentage of participants (Number) | |
---|---|---|
Day 15 | End point | |
Intranasal Esketamine + Oral Antidepressant | 37.2 | 62.0 |
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)
Intervention | Percentage of participants (Number) | ||
---|---|---|---|
Systolic BP >=180 | Diastolic BP >=110 | Acute hypertension | |
Intranasal Esketamine + Oral Antidepressant | 2.2 | 2.4 | 4.1 |
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)
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine + Oral AD | 0.0 |
Oral AD+ Intranasal Placebo | 1.0 |
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)
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine + Oral AD | 0.0 |
Oral AD+ Intranasal Placebo | 1.0 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -10.4 |
Oral AD+ Intranasal Placebo | -16.1 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -1.3 |
Oral AD+ Intranasal Placebo | -13.8 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -0.067 |
Oral AD+ Intranasal Placebo | -0.096 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -0.023 |
Oral AD+ Intranasal Placebo | -0.073 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 7.5 |
Oral AD+ Intranasal Placebo | 10.9 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 3.0 |
Oral AD+ Intranasal Placebo | 8.4 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 2.2 |
Oral AD+ Intranasal Placebo | 4.0 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 1.4 |
Oral AD+ Intranasal Placebo | 2.6 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 7.5 |
Oral AD+ Intranasal Placebo | 12.5 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 4.4 |
Oral AD+ Intranasal Placebo | 11.4 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 3.3 |
Oral AD+ Intranasal Placebo | 5.9 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 1.7 |
Oral AD+ Intranasal Placebo | 4.7 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 4.7 |
Oral AD+ Intranasal Placebo | 7.2 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 2.2 |
Oral AD+ Intranasal Placebo | 6.8 |
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)
Intervention | Days (Median) |
---|---|
Intranasal Esketamine + Oral AD | NA |
Oral AD+ Intranasal Placebo | 273.0 |
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)
Intervention | Days (Median) |
---|---|
Intranasal Esketamine + Oral AD | 635.0 |
Oral AD+ Intranasal Placebo | 88.0 |
Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA) (NCT02363270)
Timeframe: 30 minutes
Intervention | Participants (Count of Participants) |
---|---|
IV Push Group | 22 |
IV Drip Group | 13 |
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
Intervention | score on a scale (Mean) |
---|---|
Morphine Group | 4.4 |
Ketamine Group | 4.2 |
1 review available for ketamine and Dizzyness
Article | Year |
---|---|
Adverse Effects of Esketamine for the Treatment of Major Depression Disorder: Findings from Randomized Controlled Trials.
Topics: Depression; Dizziness; Humans; Hypesthesia; Ketamine; Nausea; Paresthesia; Randomized Controlled Tri | 2022 |
6 trials available for ketamine and Dizzyness
Article | Year |
---|---|
Effect of subanesthetic dose of esketamine on postoperative rehabilitation in elderly patients undergoing hip arthroplasty.
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.
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.
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.
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.
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.
Topics: Administration, Inhalation; Analgesics, Non-Narcotic; Anesthesia Recovery Period; Anesthesia, Inhala | 2012 |
4 other studies available for ketamine and Dizzyness
Article | Year |
---|---|
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.
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.
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.
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.
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.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Blood Pressure; Dizziness; Dose-Response Relationship, | 2015 |
Ketamine-induced emergence reactions after desflurane anaesthesia.
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.
Topics: Anal Canal; Anesthesia Recovery Period; Anesthesia, Intravenous; Anesthetics, Combined; Anesthetics, | 2008 |