NCT00195845

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

April 17, 2017

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Cognitive Function

    6 Months

Study Arms (2)

Double-Blind Galantamine vs Placebo

EXPERIMENTAL

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

Drug: Galantamine

Placebo Control Group

PLACEBO COMPARATOR

Placebo-Controlled Group

Drug: Placebos

Interventions

GalantamineDRUG
Double-Blind Galantamine vs Placebo
PlacebosDRUG
Placebo Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert T Dunn, MD, PhD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2003

Primary Completion

September 1, 2006

Study Completion

February 1, 2007

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)