NCT00319319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

April 26, 2006

Last Update Submit

April 18, 2007

Conditions

Depressive Disorder

Keywords

major depressive disorder,serotonin selective reuptake inhibitor,mecamylamine,controlled trial,cigarette smoking

Outcome Measures

Primary Outcomes (2)

  • Hamilton Depression Rating Scale

  • Beck Depression Inventory

Secondary Outcomes (3)

  • Cigarette Smoking

  • Quality of Life

  • Clinical Global Impression Scale

Interventions

Mecamylamine hydrochloride (Inversine)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • George TP, Sacco KA, Vessicchio JC, Weinberger AH, Shytle RD. Nicotinic antagonist augmentation of selective serotonin reuptake inhibitor-refractory major depressive disorder: a preliminary study. J Clin Psychopharmacol. 2008 Jun;28(3):340-4. doi: 10.1097/JCP.0b013e318172b49e.

    PMID: 18480694DERIVED

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, MajorCigarette Smoking

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersTobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

NorbornanesBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Tony P. George, M.D.

    Yale University School of Medicine, Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

January 1, 2003

Study Completion

January 1, 2007

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

US(1)