Trial · NCT00563797
Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence
NCT00563797, Phase 3, Completed, Yale University; results first posted 2016-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence. Trials, record NCT00563797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00563797
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence
- NCT number
- NCT00563797
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Alcohol Dependence, Depression
- Interventions
- Mecamylamine, Placebo
- First posted
- 2007-11-26
- Last updated
- 2016-04-18
- Results first posted
- 2016-04-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Drinking Days | 25 weeks | Measured with time line follow back measures |
| Primary | Depression - Measured Using the HAMD Total Score | 12 weeks | The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients. Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to \>23 (Very Severe Depression) |
| Secondary | Mean Percentage of Number of Drinking Days by Smoking Status | 25 weeks | Two-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo. |
| Secondary | Mean Percentage of Heavy Drinking Days by Smoking | 25 weeks | The two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo. |
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 | Number of Drinking Days | 25 weeks | days | MEAN | |
| PRIMARY | Depression - Measured Using the HAMD Total Score | 12 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Percentage of Number of Drinking Days by Smoking Status | 25 weeks | Percentage of Drinking Days | MEAN | |
| SECONDARY | Mean Percentage of Heavy Drinking Days by Smoking | 25 weeks | percentage of Heavy Drinking Days | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Drinking Days | Placebo | 17.6 | Standard Deviation 6.570 | days | |
| Number of Drinking Days | Mecamylamine | 12.6 | Standard Deviation 6.570 | days | |
| Depression - Measured Using the HAMD Total Score | Mecamylamine | 8.212 | Standard Deviation 1.592 | units on a scale | |
| Depression - Measured Using the HAMD Total Score | Placebo | 8.10 | Standard Deviation 1.60 | units on a scale | |
| Mean Percentage of Number of Drinking Days by Smoking Status | Mecamylamine | Smokers | 21.34 | Standard Deviation 21.96 | Percentage of Drinking Days |
| Mean Percentage of Number of Drinking Days by Smoking Status | Placebo | Smokers | 4.57 | Standard Deviation 6.19 | Percentage of Drinking Days |
| Mean Percentage of Number of Drinking Days by Smoking Status | Mecamylamine | Non-Smokers | 14.76 | Standard Deviation 18.63 | Percentage of Drinking Days |
| Mean Percentage of Number of Drinking Days by Smoking Status | Placebo | Non-Smokers | 48.81 | Standard Deviation 35.22 | Percentage of Drinking Days |
| Mean Percentage of Heavy Drinking Days by Smoking | Mecamylamine | Smokers | 15.14 | Standard Deviation 19.48 | percentage of Heavy Drinking Days |
| Mean Percentage of Heavy Drinking Days by Smoking | Placebo | Smokers | 1.68 | Standard Deviation 2.47 | percentage of Heavy Drinking Days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mecamylamine | 11 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | Received Allocated Intervention | Mecamylamine | 11 | |
| Overall Study | Received Allocated Intervention | Placebo | 10 | |
| Overall Study | Follow-Up | Mecamylamine | 11 | |
| Overall Study | Follow-Up | Placebo | 10 | |
| Overall Study | COMPLETED | Mecamylamine | 4 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Mecamylamine | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events10
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 | Vomiting/Diarrhea | Gastrointestinal disorders | Mecamylamine | 1 | 11 | |
| other | Vomiting/Diarrhea | Gastrointestinal disorders | Placebo | 0 | 10 | |
| other | Relapse to Drinking | General disorders | Mecamylamine | 1 | 11 | |
| other | Relapse to Drinking | General disorders | Placebo | 1 | 10 | |
| other | Worsening of Depression | Psychiatric disorders | Mecamylamine | 1 | 11 | |
| other | Worsening of Depression | Psychiatric disorders | Placebo | 0 | 10 | |
| other | Calcified Granuloma | General disorders | Mecamylamine | 0 | 11 | |
| other | Calcified Granuloma | General disorders | Placebo | 1 | 10 | |
| other | Rash | Skin and subcutaneous tissue disorders | Mecamylamine | 0 | 11 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 2 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mecamylamine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Mecamylamine | 3 | 11 |
| Total, other adverse events | Placebo | 4 | 10 |
| Total, serious adverse events | Mecamylamine | 0 | 11 |
| Total, serious adverse events | Placebo | 0 | 10 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mecamylamine vs Placebo: 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/NCT00563797
GET https://conductscience.org/api/trials/v1/NCT00563797/registered