NCT00181636

Brief Summary

The purpose of the study is to determine whether the investigational drug galantamine-CR (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar patients with stable mood. This study is being done because a large proportion of patients with bipolar disorder experience significant memory problems, even when their mood is stable, after adequate treatment. These memory problems have been associated with poor daily social functioning. Studying galantamine-CR in this population may provide a new clinical way to combat memory problems in stable patients with bipolar disorder.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 24, 2007

Status Verified

April 1, 2007

First QC Date

September 12, 2005

Last Update Submit

April 23, 2007

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • neurocognitive testing at last study visit (18 weeks)

Interventions

Galantamine-CRDRUG

Eligibility Criteria

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

You may qualify if:

  • DSM-IV diagnostic criteria for bipolar disorder
  • men or women aged 18-65
  • a baseline Hamilton-D17 score of \< 10 at screen visit
  • a baseline YMRS score of \< 10 at screen visit
  • no acute episodes of depression or mania for the previous 12 weeks.
  • written informed consent

You may not qualify if:

  • Subjects with current suicidal ideation
  • Pregnant women or women of childbearing potential
  • Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
  • History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months
  • History of multiple adverse drug reactions
  • Patients with mood congruent or mood incongruent psychotic features Subjects who are active smokers or who stopped smoking less than 3 months prior to enrollment; Clinical or laboratory evidence of hypothyroidism
  • Patients who have had an episode of acute depression or mania during the 12 weeks prior to enrollment
  • Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment
  • Patients with physical contraindications to magnetic resonance spectroscopy (ferrous surgical clips, cardiac pacemakers, ferrous prosthesis)
  • Patients taking any of the following medications: other cholinesterase inhibitors, succinylcholine, neuromuscular blocking agents, cholinergic agonists (e.g., bethanechol), cimetidine, ketoconazole, erythromycin, fluoxetine, paroxetine, and fluvoxamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Bipolar Clinic and Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Iosifescu DV, Moore CM, Deckersbach T, Tilley CA, Ostacher MJ, Sachs GS, Nierenberg AA. Galantamine-ER for cognitive dysfunction in bipolar disorder and correlation with hippocampal neuronal viability: a proof-of-concept study. CNS Neurosci Ther. 2009 Winter;15(4):309-19. doi: 10.1111/j.1755-5949.2009.00090.x.

    PMID: 19889129DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Dan V Iosifescu, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Completion

October 1, 2006

Last Updated

April 24, 2007

Record last verified: 2007-04

Locations

US(1)