Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence

NCT00563797 | Completed Phase 3 Results DMC

• 1 other identifier: 0705002629
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day) versus placebo in reducing depressive and alcohol symptoms in patients with depression and co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce depressive symptoms and decrease alcohol consumption compared to placebo in patients with depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake inhibitor (SSRI).

Conditions

Alcohol Dependence; Depression

Keywords

treatment; alcohol dependence; depression; mecamylamine

Outcome Measures

Primary Outcomes (2)

• Number of Drinking Days

  Measured with time line follow back measures

  25 weeks

• Depression - Measured Using the HAMD Total Score

  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)

  12 weeks

Secondary Outcomes (2)

• Mean Percentage of Number of Drinking Days by Smoking Status

  25 weeks

• Mean Percentage of Heavy Drinking Days by Smoking

  25 weeks

Study Arms (2)

Mecamylamine

EXPERIMENTAL

Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.

Drug: Mecamylamine

Placebo

PLACEBO COMPARATOR

Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.

Drug: Placebo

Interventions

Mecamylamine DRUG

mecamylamine 10mg/day for 12 weeks

Mecamylamine

Placebo DRUG

Placebo pill

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with the DSM-IV diagnosis of Major Depression (MD) and Alcohol Dependence (AD) (using the SCID).
• Individuals who have been on a stable SSRI dose for 2 weeks.
• Smokers and non-smokers (smokers are defined as smoking more than 5 cigarettes per day).
• Individuals who have a history of substance dependence (other than alcohol, tobacco and cocaine) but have not met criteria for substance dependence in the past 30 days will be included (using the SCID).
• Women of childbearing potential must have a negative pregnancy test and use an acceptable method of contraception.
• Individuals who are able to participate psychologically and physically; give informed consent; complete the assessments; take the study medication; and otherwise participate in the trial. A post-consent test will be given to assess patient's capacity to give informed consent.

You may not qualify if:

• Females who are pregnant or lactating.
• Patients may not be taking medications thought to influence drinking behavior, including: acamprosate, disulfiram, naltrexone, or ondansetron.
• Patients with significant underlying medical conditions, such as cerebral, renal, thyroid, hepatic or cardiac pathology, which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study.
• Patients with a history of glaucoma, prostatic hypertrophy, urethral obstruction, cerebral arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to mecamylamine.
• Patients who meet current SCID criteria for the following major Axis I diagnosis (Posttraumatic Stress Disorders (PTSD), Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
• Patients with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT more than 5 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP higher than 200/120).
• Patients on pharmacological treatments for alcohol and/or nicotine dependence. (8) Patients taking bethanechol. (9) Patients at risk for suicide.

Sponsors & Collaborators

• Yale University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcoholism; Depression

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Norbornanes; Bridged Bicyclo Compounds; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Elizabeth Ralevski
• Organization: Yale University School Of Medicine Department of Psychiatry

elizabeth.ralevski@yale.edu

203-932-5711

Study Officials

• Elizabeth Ralevski, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 18, 2016
• Results First Posted: April 18, 2016

Record last verified: 2016-03

Locations

US (1)