Yale School of Medicine

Research Studies at Yale

Research Studies at Yale

Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence

For Patients For Researchers

Conditions: Alcohol Dependence; Depression

What is the purpose of this trial?

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).


Dates: August 2007 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 21 Years - 65 Years
Gender Eligible: Both

Inclusion Criteria:

1. Individuals with the DSM-IV diagnosis of Major Depression (MD) and Alcohol Dependence
(AD) (using the SCID).

2. Individuals who have been on a stable SSRI dose for 2 weeks.

3. Smokers and non-smokers (smokers are defined as smoking more than 5 cigarettes per
day).

4. 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).

5. Women of childbearing potential must have a negative pregnancy test and use an
acceptable method of contraception.

6. 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.

Exclusion Criteria:

1. Females who are pregnant or lactating.

2. Patients may not be taking medications thought to influence drinking behavior,
including: acamprosate, disulfiram, naltrexone, or ondansetron.

3. 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.

4. Patients with a history of glaucoma, prostatic hypertrophy, urethral obstruction,
cerebral arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to
mecamylamine.

5. Patients who meet current SCID criteria for the following major Axis I diagnosis
(Posttraumatic Stress Disorders (PTSD), Bipolar Disorders, Schizophrenia and
Schizophrenia-type Disorders).

6. 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).

7. Patients on pharmacological treatments for alcohol and/or nicotine dependence. (8)
Patients taking bethanechol. (9) Patients at risk for suicide.

Sponsors: National Alliance for Research on Schizophrenia and Depression, Yale University
Phase: Phase 3

First Received: November 21, 2007 
Last Updated: June 10, 2009
Clinicaltrials.gov ID: NCT00563797
Study HIC # 0705002629

Conditions: Alcohol Dependence; Depression

Intervention: Drug: Mecamylamine

What is the purpose of this trial?

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).


show additional information...

Dates: August 2007 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 21 Years - 65 Years
Gender Eligible: Both

Inclusion Criteria:

1. Individuals with the DSM-IV diagnosis of Major Depression (MD) and Alcohol Dependence
(AD) (using the SCID).

2. Individuals who have been on a stable SSRI dose for 2 weeks.

3. Smokers and non-smokers (smokers are defined as smoking more than 5 cigarettes per
day).

4. 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).

5. Women of childbearing potential must have a negative pregnancy test and use an
acceptable method of contraception.

6. 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.

Exclusion Criteria:

1. Females who are pregnant or lactating.

2. Patients may not be taking medications thought to influence drinking behavior,
including: acamprosate, disulfiram, naltrexone, or ondansetron.

3. 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.

4. Patients with a history of glaucoma, prostatic hypertrophy, urethral obstruction,
cerebral arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to
mecamylamine.

5. Patients who meet current SCID criteria for the following major Axis I diagnosis
(Posttraumatic Stress Disorders (PTSD), Bipolar Disorders, Schizophrenia and
Schizophrenia-type Disorders).

6. 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).

7. Patients on pharmacological treatments for alcohol and/or nicotine dependence. (8)
Patients taking bethanechol. (9) Patients at risk for suicide.


Additional Location

Connecticut

Sponsors: National Alliance for Research on Schizophrenia and Depression, Yale University
Phase: Phase 3

First Received: November 21, 2007 
Last Updated: June 10, 2009
Clinicaltrials.gov ID: NCT00563797
Study HIC # 0705002629

Participate in this trial

For more information about this trial, contact:

Elizabeth Ralevski, Ph.D.
203-932-5711 Ext. 4282
elizabeth.ralevski@yale.edu


Yale Researcher

Ralevski, Elizabeth
Principal Investigator  

HIC # 0805003779