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Nicotinic Receptor Augmentation of SSRI Antidepressants

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ClinicalTrials.gov Identifier: NCT00319319
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 19, 2007
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Collaborator:
Information provided by:

Study Description
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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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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 ClinicalTrials.gov identifier (NCT number): 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

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
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,
mecamylamine,
controlled trial,
cigarette smoking

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Mecamylamine
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