Trial · NCT00376220
A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
NCT00376220, Phase 2, Completed, Johns Hopkins University; results first posted 2017-04-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression. Trials, record NCT00376220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00376220
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
- NCT number
- NCT00376220
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 94 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Bipolar Disorder
- Interventions
- Riluzole, Placebo
- First posted
- 2006-09-14
- Last updated
- 2017-04-11
- Results first posted
- 2017-04-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. | 8 weeks | The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a \> 50% reduction in MADRS score from baseline. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. | 8 weeks | Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. | Active Treatment Group | Baseline MADRS | 32.4 | Standard Deviation 1.0 | units on a scale |
| Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. | Inactive/Placebo Group | Baseline MADRS | 30.4 | Standard Deviation 0.9 | units on a scale |
| Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. | Active Treatment Group | Week 8 | 21.7 | Standard Deviation 1.8 | units on a scale |
| Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. | Inactive/Placebo Group | Week 8 | 19.0 | Standard Deviation 2 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Treatment Group | 47 | |
| Overall Study | STARTED | Inactive/ Placebo Group | 47 | |
| Overall Study | COMPLETED | Active Treatment Group | 37 | |
| Overall Study | COMPLETED | Inactive/ Placebo Group | 35 | |
| Overall Study | NOT COMPLETED | Active Treatment Group | 10 | |
| Overall Study | NOT COMPLETED | Inactive/ Placebo Group | 12 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Treatment Group | ||
| Total, all-cause mortality | Inactive/Placebo Group | ||
| Total, other adverse events | Active Treatment Group | 0 | 47 |
| Total, other adverse events | Inactive/Placebo Group | 0 | 47 |
| Total, serious adverse events | Active Treatment Group | 0 | 47 |
| Total, serious adverse events | Inactive/Placebo Group | 0 | 47 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Active Treatment Group vs Inactive/Placebo Group: serious adverse events |
Source Trial comparisons
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/NCT00376220
GET https://conductscience.org/api/trials/v1/NCT00376220/registered