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dextroamphetamine and Depressive Disorder, Major

dextroamphetamine has been researched along with Depressive Disorder, Major in 14 studies

Dextroamphetamine: The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.
(S)-amphetamine : A 1-phenylpropan-2-amine that has S configuration.

Depressive Disorder, Major: Disorder in which five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Symptoms include: depressed mood most of the day, nearly every daily; markedly diminished interest or pleasure in activities most of the day, nearly every day; significant weight loss when not dieting or weight gain; Insomnia or hypersomnia nearly every day; psychomotor agitation or retardation nearly every day; fatigue or loss of energy nearly every day; feelings of worthlessness or excessive or inappropriate guilt; diminished ability to think or concentrate, or indecisiveness, nearly every day; or recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt. (DSM-5)

Research Excerpts

ExcerptRelevanceReference
"The use of traditional psychostimulants (methylphenidate and dexamphetamine) and stimulant-like drugs (modafinil and armodafinil) for the treatment of depression is a growing concern given the lack of research evidence supporting their effectiveness."4.93Stimulants for depression: On the up and up? ( Bassett, D; Boyce, P; Byrow, Y; Hopwood, M; Lyndon, W; Malhi, GS; Mulder, R; Murray, G; Porter, R; Singh, A, 2016)
"Total sleep deprivation (TSD) results in an acute emotional perturbation, which yields a transient antidepressant effect."3.30Characterization of the central nervous system penetrant and selective purine P2X7 receptor antagonist JNJ-54175446 in patients with major depressive disorder. ( Benes, H; Bhatacharya, A; Browning, M; Ceusters, M; de Boer, P; Drevets, WC; Jacobs, GE; Recourt, K; van der Ark, P; van Gerven, JMA; van Nueten, L, 2023)
"This is the first report of the pharmacodynamic (PD) effects of the selective, potent and brain-penetrant P2X7 receptor (P2X7R) antagonist JNJ-54175446."2.94Characterisation of the pharmacodynamic effects of the P2X7 receptor antagonist JNJ-54175446 using an oral dexamphetamine challenge model in healthy males in a randomised, double-blind, placebo-controlled, multiple ascending dose trial. ( de Boer, P; de Kam, M; Drevets, W; Jacobs, G; Kanhai, K; Ravenstijn, P; Recourt, K; Siebenga, P; Timmers, M; van der Aart, J; van Gerven, J; van Nueten, L; Zuiker, R, 2020)
" By study phase, Eight of 27 (30%) patients remitted with initial dosing of tranylcypromine up to 60 mg/d, 6/18 (33%) remitted with above PDR dosing of tranylcypromine up to 120 mg/d, and 1/6 (17%) to adding dextroamphetamine."2.79How treatable is refractory depression? ( Deliyannides, DA; McGrath, PJ; Stewart, JW, 2014)
"2% (53/88) receiving lisdexamfetamine dimesylate had ≥ 1 treatment-emergent adverse event, the most frequent with lisdexamfetamine dimesylate being dry mouth and headache (both 11."2.78A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. ( Cutler, AJ; Gao, J; Geibel, BB; Lasser, R; Patkar, AA; Richards, C; Sambunaris, A; Trivedi, MH, 2013)
"Although there is no pharmacological treatment for autism spectrum disorder (ASD) itself, behavioral and pharmacological therapies have been used to address its symptoms and common comorbidities."1.62Medication Use in the Management of Comorbidities Among Individuals With Autism Spectrum Disorder From a Large Nationwide Insurance Database. ( Avillach, P; Feroe, AG; Greenspun, P; Gutiérrez-Sacristán, A; Kohane, IS; Mousavi, S; Surati, R; Uppal, N, 2021)
"The pathophysiology of major depressive disorder (MDD) includes disturbances in several neuroanatomical substrates and neurotransmitter systems."1.33Functional neuroanatomical substrates of altered reward processing in major depressive disorder revealed by a dopaminergic probe. ( Busto, UE; Graham, SJ; Herrmann, N; Hevenor, S; Mayberg, HS; Naranjo, CA; Tremblay, LK, 2005)
"The authors attempted to treat Major Depressive Disorder (MDD) suboptimally responsive to one of the newer (second-generation) antidepressants by augmentation with a psychostimulant medication."1.30Psychostimulant augmentation of second generation antidepressants: a case series. ( Anand, VS; Masand, PS; Tanquary, JF, 1998)

Research

Studies (14)

TimeframeStudies, this research(%)All Research%
pre-19901 (7.14)18.7374
1990's1 (7.14)18.2507
2000's3 (21.43)29.6817
2010's6 (42.86)24.3611
2020's3 (21.43)2.80

Authors

AuthorsStudies
Recourt, K2
de Boer, P2
van der Ark, P1
Benes, H1
van Gerven, JMA1
Ceusters, M1
van Nueten, L2
Drevets, WC1
Bhatacharya, A1
Browning, M1
Jacobs, GE1
van der Aart, J1
Jacobs, G1
de Kam, M1
Drevets, W1
Kanhai, K1
Siebenga, P1
Zuiker, R1
Ravenstijn, P1
Timmers, M1
van Gerven, J1
Feroe, AG1
Uppal, N1
Gutiérrez-Sacristán, A1
Mousavi, S1
Greenspun, P1
Surati, R1
Kohane, IS1
Avillach, P1
McIntyre, RS1
Lee, Y1
Zhou, AJ1
Rosenblat, JD1
Peters, EM1
Lam, RW1
Kennedy, SH1
Rong, C1
Jerrell, JM1
Trivedi, MH2
Cutler, AJ1
Richards, C1
Lasser, R2
Geibel, BB1
Gao, J1
Sambunaris, A2
Patkar, AA1
Madhoo, M1
Keefe, RS1
Roth, RM1
Wu, J1
Anderson, CS1
Stewart, JW1
Deliyannides, DA1
McGrath, PJ1
Malhi, GS1
Byrow, Y1
Bassett, D1
Boyce, P1
Hopwood, M1
Lyndon, W1
Mulder, R1
Porter, R1
Singh, A1
Murray, G1
Ng, B1
Howland, RH1
Tremblay, LK1
Naranjo, CA1
Graham, SJ1
Herrmann, N1
Mayberg, HS1
Hevenor, S1
Busto, UE1
Pogarell, O1
Koch, W1
Pöpperl, G1
Tatsch, K1
Jakob, F1
Mulert, C1
Grossheinrich, N1
Rupprecht, R1
Möller, HJ1
Hegerl, U1
Padberg, F1
Ward, NG1
Lampe, TH1
Masand, PS1
Anand, VS1
Tanquary, JF1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant[NCT00905424]Phase 2246 participants (Actual)Interventional2009-07-30Completed
Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of [NCT00985725]Phase 2143 participants (Actual)Interventional2009-10-29Completed
A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.[NCT00296686]Phase 431 participants (Actual)Interventional2001-09-30Terminated (stopped due to Study is no longer funded.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Non-remitters)-7.1
Antidepressant + Placebo (Non-remitters)-4.9

Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF

The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Non-remitters)-4.9
Antidepressant + Placebo (Non-remitters)-4.0

Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6

MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Non-remitters)-5.3
Antidepressant + Placebo (Non-remitters)-2.3

Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6

QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Non-remitters)-2.4
Antidepressant + Placebo (Non-remitters)-1.2

Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6

Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Non-remitters)-3.7
Antidepressant + Placebo (Non-remitters)-1.7

Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Remitters)0.1
Antidepressant + Placebo (Remitters)-1.1

Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF

The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Remitters)-0.8
Antidepressant + Placebo (Remitters)-1.6

Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6

MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue. (NCT00905424)
Timeframe: Augmentation baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Remitters)-4.0
Antidepressant + Placebo (Remitters)-0.2

Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6

QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. (NCT00905424)
Timeframe: Augmentation baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Remitters)-1.9
Antidepressant + Placebo (Remitters)-0.4

Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6

Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

InterventionUnits on a scale (Least Squares Mean)
Antidepressant + SPD489 (Remitters)-1.6
Antidepressant + Placebo (Remitters)-0.6

Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00905424)
Timeframe: 6 weeks

InterventionPercent of Participants (Number)
Antidepressant + SPD489 (Non-remitters)60.0
Antidepressant + Placebo (Non-remitters)45.3

Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00905424)
Timeframe: 6 weeks

InterventionPercent of participants (Number)
Antidepressant + SPD489 (Remitters)65.2
Antidepressant + Placebo (Remitters)52.4

Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: Augmentation baseline

,
InterventionPercent of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Antidepressant + Placebo (Non-remitters)1.612.534.448.43.100
Antidepressant + SPD489 (Non-remitters)1.520.040.032.36.200

Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: 6 weeks

,
InterventionPercent of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Antidepressant + Placebo (Non-remitters)14.524.222.629.09.700
Antidepressant + SPD489 (Non-remitters)27.031.730.29.51.600

Assessment in Remitters of CGI-S at Augmentation Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: Augmentation Baseline

,
InterventionPercent of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Antidepressant + Placebo (Remitters)23.871.44.80000
Antidepressant + SPD489 (Remitters)26.147.821.74.3000

Assessment in Remitters of CGI-S at Week 6

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: 6 weeks

,
InterventionPercent of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Antidepressant + Placebo (Remitters)61.923.89.54.8000
Antidepressant + SPD489 (Remitters)50.036.413.60000

Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6

BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

,
InterventionUnits on a scale (Least Squares Mean)
Global Executive CompositeBehavioral Regulation IndexMetacognition Index
Antidepressant + Placebo (Non-remitters)-1.7-1.7-1.5
Antidepressant + SPD489 (Non-remitters)-4.7-3.7-4.8

Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6

BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning. (NCT00905424)
Timeframe: Augmentation baseline and 6 weeks

,
InterventionUnits on a scale (Least Squares Mean)
Global Executive CompositeBehavioral Regulation IndexMetacognition Index
Antidepressant + Placebo (Remitters)-2.7-1.5-3.4
Antidepressant + SPD489 (Remitters)-0.9-0.4-1.1

Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11

ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT00985725)
Timeframe: Baseline and week 11

InterventionScores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)-9.4
Placebo-5.9

Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)

BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT00985725)
Timeframe: Baseline and week 9

InterventionT-scores (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)-21.2
Placebo-13.2

Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF

This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. (NCT00985725)
Timeframe: Baseline and week 9

InterventionScores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)2.5
Placebo2.4

Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF

This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. (NCT00985725)
Timeframe: Baseline and week 9

InterventionScores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)2.7
Placebo1.6

Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint

The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity. (NCT00985725)
Timeframe: Baseline and up to 9 weeks/Endpoint

InterventionScores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)-20.4
Placebo-15.9

Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00985725)
Timeframe: Baseline and week 9

InterventionScores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)-5.0
Placebo-3.1

Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9

The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies. (NCT00985725)
Timeframe: Baseline and week 9

InterventionScores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)-0.1
Placebo0.0

Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF

The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety. (NCT00985725)
Timeframe: Baseline and week 9

InterventionScores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)-4.4
Placebo-3.8

Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00985725)
Timeframe: Week 9

Interventionpercentage of participants (Number)
Lisdexamfetamine Dimesylate (LDX)60.6
Placebo38.9

Change From Baseline in BRIEF-A T-scores at Week 9, LOCF

BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT00985725)
Timeframe: Baseline and week 9

,
InterventionT-scores (Least Squares Mean)
Behavioral recognition indexInhibit subscaleShift subscaleEmotional control subscaleSelf-monitor subscaleMetacognition indexInitiate subscaleWorking memory subscalePlan/Organize subscaleTask monitor subscaleOrganization of materials subscale
Lisdexamfetamine Dimesylate (LDX)-17.4-13.5-16.2-13.8-13.8-21.1-19.4-20.1-18.7-16.8-15.2
Placebo-12.3-9.3-10.6-10.1-10.7-12.2-10.8-11.0-11.3-11.9-8.2

Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint

This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better. (NCT00985725)
Timeframe: Baseline and up to 9 weeks/Endpoint

,
InterventionResponse scores (Mean)
Complex information speed processing indexExecutive function indexNeurocognitive index
Lisdexamfetamine Dimesylate (LDX)8.711.011.5
Placebo3.76.02.5

Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint

The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction. (NCT00985725)
Timeframe: Baseline and up to 9 weeks/Endpoint

,
InterventionScores on a scale (Mean)
Physical health activitiesOverall life satisfaction
Lisdexamfetamine Dimesylate (LDX)17.912.1
Placebo8.29.1

Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9

The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health). (NCT00985725)
Timeframe: Baseline and week 9

,
InterventionScores on a scale (Mean)
Aggregate physicalAggregate mental
Lisdexamfetamine Dimesylate (LDX)-0.100.69
Placebo-0.230.63

Percent of Participants With CGI-S at up to 9 Weeks/Endpoint

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00985725)
Timeframe: Up to 9 weeks/Endpoint

,
Interventionpercentage of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Lisdexamfetamine Dimesylate (LDX)21.740.620.314.52.90.00.0
Placebo15.923.224.634.81.40.00.0

Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00985725)
Timeframe: Baseline

,
Interventionpercentage of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Lisdexamfetamine Dimesylate (LDX)0.07.042.345.14.21.40.0
Placebo2.88.336.148.64.20.00.0

Reviews

2 reviews available for dextroamphetamine and Depressive Disorder, Major

ArticleYear
The Efficacy of Psychostimulants in Major Depressive Episodes: A Systematic Review and Meta-Analysis.
    Journal of clinical psychopharmacology, 2017, Volume: 37, Issue:4

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Depressive Disorder, Major; Dextroamphetami

2017
Stimulants for depression: On the up and up?
    The Australian and New Zealand journal of psychiatry, 2016, Volume: 50, Issue:3

    Topics: Amphetamine; Antidepressive Agents; Benzhydryl Compounds; Bipolar Disorder; Central Nervous System S

2016

Trials

5 trials available for dextroamphetamine and Depressive Disorder, Major

ArticleYear
Characterization of the central nervous system penetrant and selective purine P2X7 receptor antagonist JNJ-54175446 in patients with major depressive disorder.
    Translational psychiatry, 2023, 07-24, Volume: 13, Issue:1

    Topics: Central Nervous System; Depressive Disorder, Major; Dextroamphetamine; Humans; Purinergic P2X Recept

2023
Characterisation of the pharmacodynamic effects of the P2X7 receptor antagonist JNJ-54175446 using an oral dexamphetamine challenge model in healthy males in a randomised, double-blind, placebo-controlled, multiple ascending dose trial.
    Journal of psychopharmacology (Oxford, England), 2020, Volume: 34, Issue:9

    Topics: Adolescent; Adult; Central Nervous System Stimulants; Depressive Disorder, Major; Dextroamphetamine;

2020
A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram.
    The Journal of clinical psychiatry, 2013, Volume: 74, Issue:8

    Topics: Adolescent; Adult; Antidepressive Agents, Second-Generation; Central Nervous System Stimulants; Cita

2013
Lisdexamfetamine dimesylate augmentation in adults with persistent executive dysfunction after partial or full remission of major depressive disorder.
    Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2014, Volume: 39, Issue:6

    Topics: Adult; Antidepressive Agents; Cognition Disorders; Depressive Disorder, Major; Dextroamphetamine; Do

2014
How treatable is refractory depression?
    Journal of affective disorders, 2014, Volume: 167

    Topics: Adult; Antidepressive Agents; Central Nervous System Stimulants; Depressive Disorder, Major; Depress

2014

Other Studies

7 other studies available for dextroamphetamine and Depressive Disorder, Major

ArticleYear
Medication Use in the Management of Comorbidities Among Individuals With Autism Spectrum Disorder From a Large Nationwide Insurance Database.
    JAMA pediatrics, 2021, 09-01, Volume: 175, Issue:9

    Topics: Adolescent; Amphetamines; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity;

2021
Is there a role for psychostimulants in old age depression and apathy?
    International psychogeriatrics, 2009, Volume: 21, Issue:2

    Topics: Aged; Antidepressive Agents; Benzhydryl Compounds; Central Nervous System Stimulants; Depressive Dis

2009
The use of dopaminergic and stimulant drugs for the treatment of depression.
    Journal of psychosocial nursing and mental health services, 2012, Volume: 50, Issue:2

    Topics: Amphetamines; Antidepressive Agents; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hype

2012
Functional neuroanatomical substrates of altered reward processing in major depressive disorder revealed by a dopaminergic probe.
    Archives of general psychiatry, 2005, Volume: 62, Issue:11

    Topics: Adult; Affective Symptoms; Brain; Corpus Striatum; Depressive Disorder, Major; Dextroamphetamine; Di

2005
Acute prefrontal rTMS increases striatal dopamine to a similar degree as D-amphetamine.
    Psychiatry research, 2007, Dec-15, Volume: 156, Issue:3

    Topics: Benzamides; Central Nervous System Stimulants; Corpus Striatum; Depressive Disorder, Major; Dextroam

2007
A trial of dextroamphetamine in patients with involutional agitated depression.
    The Journal of clinical psychiatry, 1982, Volume: 43, Issue:1

    Topics: Aged; Depressive Disorder, Major; Desipramine; Dextroamphetamine; Female; Humans; Middle Aged; Psych

1982
Psychostimulant augmentation of second generation antidepressants: a case series.
    Depression and anxiety, 1998, Volume: 7, Issue:2

    Topics: Adult; Antidepressive Agents, Second-Generation; Central Nervous System Stimulants; Depressive Disor

1998