Trial · NCT02149836
Study to Treat Major Depressive Disorder (MDD) With a New Medication
NCT02149836, Phase 2, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Treat Major Depressive Disorder (MDD) With a New Medication. Trials, record NCT02149836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02149836
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Treat Major Depressive Disorder (MDD) With a New Medication
- NCT number
- NCT02149836
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Major Depressive Disorder, Depression
- Interventions
- ezogabine
- First posted
- 2014-05-29
- Last updated
- 2019-04-16
- Results first posted
- 2019-04-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Montgomery-Asberg Depression Rating Scale Comparison to Baseline | baseline and after end of treatment (10 weeks) | The Montgomery-Asberg Depression Rating Scale (29) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. The MADRS is specifically designed to detect changes in depression severity in the context of a medication treatment trial. |
| Secondary | Patient Rated Inventory of Side Effects (PRISE) | 8 weeks | Number of symptom events as reported by the patient in a self-report measure. PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other) |
| Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | 8 weeks | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation). |
| Secondary | Changes in Reward System Activation After Treatment With Ezogabine | baseline and post treatment (8 weeks) | Functional MRI of reward processing: The primary neuroimaging endpoint is the degree of change observed in the reward system in the brain. Although it was an outcome measure, the data format is a set of 4-dimensional statistical maps and not reported in raw data. Mean changes in activation of the ventral tegmental area (VTA) or ventral striatum (VS) in response to reward cue to reward receipt, and VTA mean change in beta weight in response to reward cue at 8 weeks as compared to baseline. The Z-score indicates the number of standard deviations away from a reference population in the same age range. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Montgomery-Asberg Depression Rating Scale Comparison to Baseline | baseline and after end of treatment (10 weeks) | 1 participant withdrew before end of study | units on a scale | MEAN |
| SECONDARY | Patient Rated Inventory of Side Effects (PRISE) | 8 weeks | events | NUMBER | |
| SECONDARY | Columbia-Suicide Severity Rating Scale (C-SSRS) | 8 weeks | units on a scale | MEAN | |
| SECONDARY | Changes in Reward System Activation After Treatment With Ezogabine | baseline and post treatment (8 weeks) | z-score | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Montgomery-Asberg Depression Rating Scale Comparison to Baseline | Ezogabine | Baseline | 29.50 | Standard Deviation 4.93 | units on a scale |
| Montgomery-Asberg Depression Rating Scale Comparison to Baseline | Ezogabine | 10 weeks | 15.83 | Standard Deviation 7.85 | units on a scale |
| Patient Rated Inventory of Side Effects (PRISE) | Ezogabine | 105 | events | ||
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Ezogabine | 0.278 | Standard Deviation 0.958 | units on a scale | |
| Changes in Reward System Activation After Treatment With Ezogabine | Ezogabine | VTA in response to reward cue | -0.043 | Standard Deviation 0.55 | z-score |
| Changes in Reward System Activation After Treatment With Ezogabine | Ezogabine | VTA in response to reward receipt | -0.021 | Standard Deviation 0.32 | z-score |
| Changes in Reward System Activation After Treatment With Ezogabine | Ezogabine | VS in response to reward cue | -0.031 | Standard Deviation 0.40 | z-score |
| Changes in Reward System Activation After Treatment With Ezogabine | Ezogabine | VS in response to reward receipt | 0.013 | Standard Deviation 0.23 | z-score |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezogabine | 18 | |
| Overall Study | COMPLETED | Ezogabine | 17 | |
| Overall Study | NOT COMPLETED | Ezogabine | 1 |
Source ClinicalTrials.gov
Adverse events14
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 | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Ezogabine | 8 | 18 | |
| other | Headache | Nervous system disorders | Ezogabine | 2 | 18 | |
| other | Somnolence | Nervous system disorders | Ezogabine | 1 | 18 | |
| other | Confusional State | Nervous system disorders | Ezogabine | 3 | 18 | |
| other | Disturbance in attention | Nervous system disorders | Ezogabine | 1 | 18 | |
| other | Illusion | Psychiatric disorders | Ezogabine | 1 | 18 | |
| other | Delayed orgasm | Psychiatric disorders | Ezogabine | 1 | 18 | |
| other | Erectile Dysfunction | Psychiatric disorders | Ezogabine | 1 | 18 | |
| other | Nausea | Psychiatric disorders | Ezogabine | 1 | 18 | |
| other | Flatulence | Gastrointestinal disorders | Ezogabine | 1 | 18 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ezogabine | 0 | 18 |
| Total, other adverse events | Ezogabine | 15 | 18 |
| Total, serious adverse events | Ezogabine | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02149836
GET https://conductscience.org/api/trials/v1/NCT02149836/registered