Trial · NCT00572117
Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder
NCT00572117, Phase 4, Completed, Stanford University; results first posted 2017-01-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder. Trials, record NCT00572117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00572117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder
- NCT number
- NCT00572117
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 12 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Bipolar Disorder, Alcoholism, Alcohol Dependence
- Interventions
- Topiramate
- First posted
- 2007-12-12
- Last updated
- 2017-01-09
- Results first posted
- 2017-01-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amount of Alcohol Consumed | Baseline and 12 weeks | Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink. |
| Secondary | Effect of Treatment on Mood Symptoms | Baseline and 12 weeks | The 17-item Hamilton Depression Rating Scale (HAM-D) is a standard measure of symptoms of depression with a scoring range of 0-53 points. Higher HAM-D scores represent more depression, so a lowering of HAM-D scores is considered a good outcome, an increase in HAM-D scores considered a worsening of outcomes. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Amount of Alcohol Consumed | Baseline and 12 weeks | number of drinks per heavy drinking day | MEAN | |
| SECONDARY | Effect of Treatment on Mood Symptoms | Baseline and 12 weeks | 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 |
|---|---|---|---|---|---|
| Amount of Alcohol Consumed | Topiramate | -1.38 | 95% Confidence Interval -4.93 to 2.17 | number of drinks per heavy drinking day | |
| Amount of Alcohol Consumed | Placebo (Inert Pill) Arm | -0.69 | 95% Confidence Interval -1.68 to 0.31 | number of drinks per heavy drinking day | |
| Effect of Treatment on Mood Symptoms | Topiramate | -2.00 | 95% Confidence Interval -6.21 to 2.21 | units on a scale | |
| Effect of Treatment on Mood Symptoms | Placebo (Inert Pill) Arm | -0.72 | 95% Confidence Interval -8.96 to 7.54 | 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 | Topiramate | 5 | |
| Overall Study | STARTED | Placebo (Inert Pill) Arm | 7 | |
| Overall Study | COMPLETED | Topiramate | 3 | |
| Overall Study | COMPLETED | Placebo (Inert Pill) Arm | 5 | |
| Overall Study | NOT COMPLETED | Topiramate | 2 | |
| Overall Study | NOT COMPLETED | Placebo (Inert Pill) Arm | 2 |
Source ClinicalTrials.gov
Adverse events4
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 | Paresthesia | Nervous system disorders | Topiramate | 1 | 5 | 1 |
| other | Paresthesia | Nervous system disorders | Placebo (Inert Pill) Arm | 1 | 7 | 1 |
| serious | Hospitalization | Psychiatric disorders | Topiramate | 0 | 5 | 0 |
| serious | Hospitalization | Psychiatric disorders | Placebo (Inert Pill) Arm | 1 | 7 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate | ||
| Total, all-cause mortality | Placebo (Inert Pill) Arm | ||
| Total, other adverse events | Topiramate | 1 | 5 |
| Total, other adverse events | Placebo (Inert Pill) Arm | 1 | 7 |
| Total, serious adverse events | Topiramate | 0 | 5 |
| Total, serious adverse events | Placebo (Inert Pill) Arm | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| K23AA016340 | Topiramate treatment of alcohol dependence in patients with bipolar disorder | OSTACHER, MICHAEL JOSHUA | STANFORD UNIVERSITY | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2007 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Topiramate vs Placebo (Inert Pill) Arm: 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/NCT00572117
GET https://conductscience.org/api/trials/v1/NCT00572117/registered