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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryNumber of Drinking Days25 weeksMeasured with time line follow back measures
PrimaryDepression - Measured Using the HAMD Total Score12 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)
SecondaryMean Percentage of Number of Drinking Days by Smoking Status25 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.
SecondaryMean Percentage of Heavy Drinking Days by Smoking25 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.

Outcomes4

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Drinking Days25 weeksdaysMEAN
PRIMARYDepression - Measured Using the HAMD Total Score12 weeksunits on a scaleMEAN
SECONDARYMean Percentage of Number of Drinking Days by Smoking Status25 weeksPercentage of Drinking DaysMEAN
SECONDARYMean Percentage of Heavy Drinking Days by Smoking25 weekspercentage of Heavy Drinking DaysMEAN

Results by group12

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

OutcomeGroupCategoryValueSpreadUnits
Number of Drinking DaysPlacebo17.6Standard Deviation 6.570days
Number of Drinking DaysMecamylamine12.6Standard Deviation 6.570days
Depression - Measured Using the HAMD Total ScoreMecamylamine8.212Standard Deviation 1.592units on a scale
Depression - Measured Using the HAMD Total ScorePlacebo8.10Standard Deviation 1.60units on a scale
Mean Percentage of Number of Drinking Days by Smoking StatusMecamylamineSmokers21.34Standard Deviation 21.96Percentage of Drinking Days
Mean Percentage of Number of Drinking Days by Smoking StatusPlaceboSmokers4.57Standard Deviation 6.19Percentage of Drinking Days
Mean Percentage of Number of Drinking Days by Smoking StatusMecamylamineNon-Smokers14.76Standard Deviation 18.63Percentage of Drinking Days
Mean Percentage of Number of Drinking Days by Smoking StatusPlaceboNon-Smokers48.81Standard Deviation 35.22Percentage of Drinking Days
Mean Percentage of Heavy Drinking Days by SmokingMecamylamineSmokers15.14Standard Deviation 19.48percentage of Heavy Drinking Days
Mean Percentage of Heavy Drinking Days by SmokingPlaceboSmokers1.68Standard Deviation 2.47percentage of Heavy Drinking Days

Participant flow10

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDMecamylamine11
Overall StudySTARTEDPlacebo10
Overall StudyReceived Allocated InterventionMecamylamine11
Overall StudyReceived Allocated InterventionPlacebo10
Overall StudyFollow-UpMecamylamine11
Overall StudyFollow-UpPlacebo10
Overall StudyCOMPLETEDMecamylamine4
Overall StudyCOMPLETEDPlacebo8
Overall StudyNOT COMPLETEDMecamylamine7
Overall StudyNOT COMPLETEDPlacebo2

Adverse events10

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherVomiting/DiarrheaGastrointestinal disordersMecamylamine111
otherVomiting/DiarrheaGastrointestinal disordersPlacebo010
otherRelapse to DrinkingGeneral disordersMecamylamine111
otherRelapse to DrinkingGeneral disordersPlacebo110
otherWorsening of DepressionPsychiatric disordersMecamylamine111
otherWorsening of DepressionPsychiatric disordersPlacebo010
otherCalcified GranulomaGeneral disordersMecamylamine011
otherCalcified GranulomaGeneral disordersPlacebo110
otherRashSkin and subcutaneous tissue disordersMecamylamine011
otherRashSkin and subcutaneous tissue disordersPlacebo210

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityMecamylamine
Total, all-cause mortalityPlacebo
Total, other adverse eventsMecamylamine311
Total, other adverse eventsPlacebo410
Total, serious adverse eventsMecamylamine011
Total, serious adverse eventsPlacebo010

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

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.

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.

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