Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00741598

Purpose

This study will examine whether extended release galantamine, a drug approved by the Food and Drug Administration to reduce cognitive impairments in people with Alzheimer's disease, can perform the same function in stable people with bipolar disorder.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Galantamine-ER Drug: Galantamine placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy and Safety of Galantamine for Dysfunction in Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Galantamine hydrobromide Galantamine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Change in scores on the California Verbal Learning Test (CVLT-II) [ Time Frame: Measured at screening and Week 16 ] [ Designated as safety issue: No ]
Change in scores on the Wisconsin Card Sorting Test (WCST) [ Time Frame: Measured at screening and Week 16 ] [ Designated as safety issue: No ]
Change in scores on the Conners' Continuous Performance Test (CPT) [ Time Frame: Measured at screening; baseline; and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Range of Impaired Functioning Tool (LIFE-RIFT) [ Time Frame: Measured at baseline and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
Quality of Life Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured at screening; baseline; and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive treatment with extended release galantamine	Drug: Galantamine-ER Galantamine-ER 8 to 24 mg per day for 16 weeks
2: Placebo Comparator Participants will receive treatment with placebo.	Drug: Galantamine placebo Galantamine placebo 8 to 24 mg per day for 16 weeks

Detailed Description:

Approximately 2.6% of Americans age 18 and older, or 5.7 million people, suffer from bipolar disorder. The manic and depressive episodes associated with bipolar disorder prevent normal functioning in individuals with the disorder, but functional impairment can occur even when bipolar disorder is in remission. Previous research indicates that this impairment in stable individuals with bipolar disorder is linked to neurocognitive deficits, such as problems with memory and attention. The drug extended release galantamine increases the level of acetylcholine, a neurotransmitter important for memory, available in the brain. This drug has already been approved by the FDA to treat neurocognitive impairment in Alzheimer's disease patients. This study will examine whether administering the drug to individuals with bipolar disorder who are in remission can also reduce their neurocognitive deficits and improve the quality of their life. The study will also examine the safety of the drug for use in the obsessive-compulsive disorder population.

Participation in this study will last about 18 weeks and will involve six study visits. Each of the first two visits will include 2 hours of clinical, physical, and self-report tests, the first for screening and the second to establish physical and mental health baseline measurements. Participants will then be randomly assigned to receive either galantamine or placebo daily for 16 weeks, and they will be provided with enough of the assigned pill to last until the next visit. Half hour visits on Weeks 4, 8, and 12 will consist of psychological self-report tests and interviews, clinical assessment of side effects from the drug, and the determination by the examining doctor and participant whether to increase, decrease, or maintain the same level of the drug. Participants will also be given enough of the drug to last until the next visit. The final visit, on Week 16, will last 2 hours and will consist of the same tests administered at the baseline visit in addition to the neuropsychological tests administered at the screening visit. The full range of tests will measure physical health, verbal memory, mental flexibility, attention, life impairment, and life satisfaction.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

The subjects with bipolar disorder must meet all of the following criteria:

DSM-IV diagnosis of Bipolar I disorder or Bipolar II disorder
A baseline Hamilton-D 17 score of less than 10 at screening visit
A baseline Young Manira Rating Scale (YMRS) score of less than 10 at screening visit
No acute episodes of depression or mania for the previous 16 weeks
Score of 17 or higher on the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire
Treated with psychiatric medications, alone or in combination, having only minimal, mild or moderate cognitive burden [as determined by a score of less than 3.5 on the MGH Cognitive Impact of Psychotropic Medications Scale (CIPMS).
Able to understand English

Exclusion Criteria

Patients meeting any of the following criteria are to be excluded from the study:

DSM-IV diagnosis of Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.
Meets DSM-IV criteria for acute manic, depressive, or mixed bipolar episode or had met full criteria for 2 consecutive weeks within the past 12 weeks prior to assessment
Treated with psychiatric medications with large effects on cognition (as determined by a MGH Cognitive Impact of Psychotropic Medications Scale score of 4.0 or above)
Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
Serious suicide or homicide risk
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
History of seizure disorder, brain injury, or any known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
The following DSM-IV diagnoses: 1) organic mental disorders; 2) any diagnosis of dementia; 3) substance use disorders, including alcohol, active within the last year; 4) schizophrenia; 5) delusional disorder; 6) psychotic disorders not elsewhere classified; 7) schizoaffective disorder; 8) major depressive disorder; 9) acute bereavement; 10) severe borderline or antisocial personality disorder
Presence of mood congruent or mood incongruent psychotic features
Clinical or laboratory evidence of hypothyroidism
History of multiple adverse drug reactions, allergy to galantamine or other AChEIs
Current use, or use within the last week, of excluded drugs (psychotropic medications and other central nervous system (CNS)-active drugs)
Taken an investigational psychotropic drug within the last year
Had electroconvulsive therapy (ECT) within the 6 months preceding enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741598

Contacts

Contact: Aleena C. Hay, BA	866-99-MOODS(6-6637)	ahay@partners.org
Contact: Colleen M. Cowperthwait, BA	866-99-MOODS(6-6637)	ccowperthwait@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Aleena C Hay, BA 866-996-6637 ahay@partners.org
Contact: Colleen M Cowperthwait, BA 866-996-6637 ccowperthwait@partners.org
Principal Investigator: Dan V. Iosifescu, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dan V. Iosifescu, MD

Massachusetts General Hospital

More Information

Additional Information:

Click here for more information on the Massachusetts General Hospital's Bipolar Clinic and Research Program. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Massachusetts General Hospital ( Dan V. Iosifescu, MD )
Study ID Numbers:	R01 MH079157, 1R01 MH079157-01A2, DATR A5-ETMA
Study First Received:	August 25, 2008
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00741598 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Disease
Galantamine
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents

Pharmacologic Actions
Cholinesterase Inhibitors
Affective Disorders, Psychotic
Pathologic Processes
Autonomic Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009