Nicotinic Receptor Augmentation of SSRI Antidepressants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319319
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 19, 2007
Donaghue Medical Research Foundation
Information provided by:
Yale University

Brief Summary:
The purpose of this study is to determine whether the nicotinic receptor antagonist mecamylamine hydrochloride (Inversine) can augment SSRI-refractory major depression symptoms, quality of life and cigarette smoking outcomes. A total of n=60 SSRI-refractory patients who are on stable doses of an SSRI are being recruited into this 8-week double-blind, randomized, placebo-controlled trial.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: Mecamylamine hydrochloride (Inversine) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind,Randomized,Placebo-Controlled Trial of Mecamylamine Hydrochloride for the Treatment of SSRI-Refractory Major Depressive Disorder.
Study Start Date : January 2003
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale
  2. Beck Depression Inventory

Secondary Outcome Measures :
  1. Cigarette Smoking
  2. Quality of Life
  3. Clinical Global Impression Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Major depression, recurrent outpatients, ages 18-65, smoker or non-smoker, on SSRI monotherapy, depression scores on HDRS-17 item scale or = 12.

Exclusion Criteria:

  • suicidal or homicidal ideation, need for inpatient or partial hospital care, systolic blood pressure <100 mm Hg, history of hypersensitivity to mecamylamine or its excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00319319

United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Donaghue Medical Research Foundation
Principal Investigator: Tony P. George, M.D. Yale University School of Medicine, Psychiatry

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00319319     History of Changes
Other Study ID Numbers: DF-02-006
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007

Keywords provided by Yale University:
major depressive disorder,
serotonin selective reuptake inhibitor,
controlled trial,
cigarette smoking

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antihypertensive Agents
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action