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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Mecamylamine
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Cholinergic Agents
Cholinergic Antagonists
Ganglionic Blockers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014