Trial · NCT03043560

Study to Treat Major Depressive Disorder With a New Medication

NCT03043560, Phase 2, Completed, James Murrough; results first posted 2020-10-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Treat Major Depressive Disorder With a New Medication. Trials, record NCT03043560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03043560

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Treat Major Depressive Disorder With a New Medication
NCT number: NCT03043560
Status: Completed
Phases: Phase 2
Enrollment: 45 participants, actual
Lead sponsor: James Murrough
Conditions: Depressive Disorder, Anhedonia
Interventions: Ezogabine, Placebos
First posted: 2017-02-06
Last updated: 2020-10-23
Results first posted: 2020-10-23
Limitations and caveats: The relatively small sample size and termination of enrollment prior to the planned target limit conclusions regarding efficacy and generalizability.

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Ventral Striatum (VS) Activation	baseline and 5 weeks	change in activation during reward anticipation within the bilateral VS from baseline (Study Visit 0) to the primary outcome visit (Study Visit 5) as measured by functional MRI during the incentive flanker task (IFT). The IFT, like the Monetary Incentive Delay task, permits discrete modeling of brain activity during anticipation of an incentive. Functional scans were preprocessed and denoised for motion and physiological noise using multi-echo independent component analysis (ME-ICA). Task-based modeling was conducted using AFNI and FSL software. The primary outcome for reward anticipation was the contrast of reward cue compared to neutral cue (reward\>neutral cue). The primary imaging outcome was analyzed using a linear mixed model with a single random intercept term treating time as discrete or continuous as appropriate.
Secondary	Change in Snaith-Hamilton Pleasure Scale (SHAPS)	baseline and 5 weeks	The SHAPS is a well-validated 14-item self-report questionnaire commonly used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater pleasure capacity. A total score can be derived by summing the responses to each item. Items answered with "strongly agree" are coded as "1", while a "strongly disagree" response was assigned a score of "4." Total scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.
Secondary	Clinical Global Impression - Improvement (CGI-I)	baseline and 5 weeks	A widely administered clinician rated global measure of the degree of improvement from the initial assessment in subject overall illness severity. 7 point scale rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Secondary	Clinical Global Impression - Severity (CGI-S)	baseline and 5 weeks	Clinician rated global measure of subject overall illness severity. a 7-point scale rated as 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Secondary	Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)	baseline and 5 weeks	A measure specifically designed to assess hedonic capacity for social and interpersonal pleasure.The ACIPS is a 17-item self-report measure scored on a likert scale, ranging from 1 (very false for me) to 6 (very true for me). Full scale from 17-102, higher score indicates higher hedonic capacity
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS)	baseline and 5 weeks	A 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Secondary	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	baseline and 5 weeks	A 12-item generic assessment instrument that measures the level of functioning. Each item is scored from 0 to 4 and the items are summed to provide a total score. The score therefore ranges from 0 to 48, with higher scores indicating greater disability.
Secondary	Temporal Experience of Pleasure Scale (TEPS)	baseline and 5 weeks	The TEPS is composed of 18-items rated on a likert-type scale ranging from 1 (Very True for me) to 6 (Very False for me), and yields two subscales. Ten items make up the TEPS-Anticipatory Pleasure (TEPS-ANT) scale with a range from 10 (not motivated) to 60 (highly motivated). The other eight TEPS items make up the TEPS-Consummatory Pleasure (TEPS-CON) scale; range from 8 (not responsive) to 48 (highly responsive). Total scores range is 18-108. Lower scores indicate greater levels of anhedonia.
Secondary	Specific Loss of Interest and Pleasure Scale (SLIPS)	baseline 5 weeks	The SLIPS is a recently developed and validated measure of anhedonia that is tailored to detect recent changes in anhedonia. A 23-item measure, each item range from 0-3. Full scale from 0 to 69, higher score indicates more recent changes.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Ventral Striatum (VS) Activation	baseline and 5 weeks	Bold Oxygen-level Dependent (BOLD) Signa	MEAN
SECONDARY	Change in Snaith-Hamilton Pleasure Scale (SHAPS)	baseline and 5 weeks	score on a scale	MEAN
SECONDARY	Clinical Global Impression - Improvement (CGI-I)	baseline and 5 weeks	score on a scale	MEAN
SECONDARY	Clinical Global Impression - Severity (CGI-S)	baseline and 5 weeks	score on a scale	MEAN
SECONDARY	Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)	baseline and 5 weeks	score on a scale	MEAN
SECONDARY	Montgomery-Asberg Depression Rating Scale (MADRS)	baseline and 5 weeks	score on a scale	MEAN
SECONDARY	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	baseline and 5 weeks	score on a scale	MEAN
SECONDARY	Temporal Experience of Pleasure Scale (TEPS)	baseline and 5 weeks	score on a scale	MEAN
SECONDARY	Specific Loss of Interest and Pleasure Scale (SLIPS)	baseline 5 weeks	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Ventral Striatum (VS) Activation	Ezogabine	baseline	-0.26	Standard Deviation 0.69	Bold Oxygen-level Dependent (BOLD) Signa
Change in Ventral Striatum (VS) Activation	Placebo	baseline	0.95	Standard Deviation 0.79	Bold Oxygen-level Dependent (BOLD) Signa
Change in Ventral Striatum (VS) Activation	Ezogabine	5 weeks	0.176	Standard Deviation 0.81	Bold Oxygen-level Dependent (BOLD) Signa
Change in Ventral Striatum (VS) Activation	Placebo	5 weeks	0.015	Standard Deviation 0.68	Bold Oxygen-level Dependent (BOLD) Signa
Change in Snaith-Hamilton Pleasure Scale (SHAPS)	Ezogabine	Baseline	38.7	Standard Deviation 8.1	score on a scale
Change in Snaith-Hamilton Pleasure Scale (SHAPS)	Placebo	Baseline	33.7	Standard Deviation 6	score on a scale
Change in Snaith-Hamilton Pleasure Scale (SHAPS)	Ezogabine	5 weeks	27.5	Standard Deviation 8.5	score on a scale
Change in Snaith-Hamilton Pleasure Scale (SHAPS)	Placebo	5 weeks	30	Standard Deviation 10.9	score on a scale
Clinical Global Impression - Improvement (CGI-I)	Ezogabine	baseline	4	Standard Deviation 0.2	score on a scale
Clinical Global Impression - Improvement (CGI-I)	Placebo	baseline	4	Standard Deviation 0.4	score on a scale

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ezogabine	21
Overall Study	STARTED	Placebo	24
Overall Study	COMPLETED	Ezogabine	20
Overall Study	COMPLETED	Placebo	21
Overall Study	NOT COMPLETED	Ezogabine	1
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Pain	Gastrointestinal disorders	Ezogabine	2	21
other	Abdominal Pain	Gastrointestinal disorders	Placebo	3	24
other	Anxiety	Psychiatric disorders	Ezogabine	1	21
other	Anxiety	Psychiatric disorders	Placebo	1	24
other	Back Pain	Musculoskeletal and connective tissue disorders	Ezogabine	0	21
other	Back Pain	Musculoskeletal and connective tissue disorders	Placebo	1	24
other	Confusional state	Psychiatric disorders	Ezogabine	4	21
other	Confusional state	Psychiatric disorders	Placebo	0	24
other	Constipation	Gastrointestinal disorders	Ezogabine	1	21
other	Constipation	Gastrointestinal disorders	Placebo	2	24

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ezogabine	0	21
Total, all-cause mortality	Placebo	0	24
Total, other adverse events	Ezogabine	21	21
Total, other adverse events	Placebo	19	24
Total, serious adverse events	Ezogabine	0	21
Total, serious adverse events	Placebo	0	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33653118	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R61MH111932	Developing Neuronal KCNQ Channel Modulators for Mood Disorders	MURROUGH, JAMES WARREN	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	NATIONAL INSTITUTE OF MENTAL HEALTH	2017 to 2018

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ezogabine vs Placebo: deaths from any cause	Trial comparisons
Ezogabine vs Placebo: serious adverse events	Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Eriksen Flanker Task	Primary outcome	ConductCognition
Monetary Incentive Delay	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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