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Nicotinic Receptor Augmentation of SSRI Antidepressants

This study has been completed.
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00319319
First received: April 26, 2006
Last updated: April 18, 2007
Last verified: April 2007
History of Changes
  Purpose

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 Intervention Phase
Depressive Disorder
 Drug: Mecamylamine hydrochloride (Inversine)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind,Randomized,Placebo-Controlled Trial of Mecamylamine Hydrochloride for the Treatment of SSRI-Refractory Major Depressive Disorder.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale
  • Beck Depression Inventory

Secondary Outcome Measures:
  • Cigarette Smoking
  • Quality of Life
  • Clinical Global Impression Scale

Estimated Enrollment: 60
Study Start Date: January 2003
Study Completion Date: January 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319319

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

Additional Information:
Program for Research in Smokers with Mental Illness, Yale University  This link exits the ClinicalTrials.gov site

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00319319     History of Changes
Other Study ID Numbers: DF-02-006
Study First Received: April 26, 2006
Last Updated: April 18, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Mecamylamine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Antihypertensive Agents
Cardiovascular 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

ClinicalTrials.gov processed this record on May 19, 2013