A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

Sponsors

Lead Sponsor: Cambridge Health Alliance

Collaborator: Northwestern University

Source Cambridge Health Alliance
Brief Summary

The purpose of this study is to determine if galantamine augmentaion improves cognition in euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of functioning and psychopathology will also be assessed.

Detailed Description

The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings.

Overall Status Completed
Start Date April 2003
Completion Date February 2007
Primary Completion Date September 2006
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Cognitive Function 6 Months
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Galantamine

Arm Group Label: Double-Blind Galantamine vs Placebo

Intervention Type: Drug

Intervention Name: Placebos

Arm Group Label: Placebo Control Group

Eligibility

Criteria:

Inclusion Criteria:

- Age 18-60; DSM-IV diagnosis of bipolar disorder, any subtype; Baseline Mini Mental Status exam above 20; MRS < 16; MADRS < 16

Exclusion Criteria:

- Current substance dependence; serious unstable medical conditions; active suicidal ideation; current DSM-IV for a major mood episodes; history of COPD, epilepsy, cardiac arrhythmia, and peptic ulcer disease; meet DSM-IV criteria for dementia

Gender: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Robert T Dunn, MD, PhD Principal Investigator Cambridge Health Alliance
Location
Facility: Cambridge Health Alliance
Location Countries

United States

Verification Date

April 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Double-Blind Galantamine vs Placebo

Type: Experimental

Description: Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction

Label: Placebo Control Group

Type: Placebo Comparator

Description: Placebo-Controlled Group

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov