Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Dan V. Iosifescu, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00741598
First received: August 25, 2008
Last updated: March 12, 2014
Last verified: March 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Galantamine for Dysfunction in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

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: Baseline ] [ Designated as safety issue: No ]
  • The Range of Impaired Functioning Tool (LIFE-RIFT) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • The Range of Impaired Functioning Tool (LIFE-RIFT) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • The Range of Impaired Functioning Tool (LIFE-RIFT) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • The Range of Impaired Functioning Tool (LIFE-RIFT) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Quality of Life Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Screening ] [ Designated as safety issue: No ]
  • Quality of Life Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Quality of Life Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Weeks 4 ] [ Designated as safety issue: No ]
  • Quality of Life Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Weeks 8 ] [ Designated as safety issue: No ]
  • Quality of Life Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Weeks 12 ] [ Designated as safety issue: No ]
  • Quality of Life Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Weeks 16 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: September 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Galantamine-ER
Participants will receive treatment with extended release galantamine
Drug: Galantamine-ER
Galantamine-ER 8 to 24 mg per day for 16 weeks
Other Name: Razadyne-ER
Placebo Comparator: Galantamine placebo
Participants will receive treatment with placebo.
Drug: Galantamine placebo
Galantamine placebo 8 to 24 mg per day for 16 weeks
Other Name: placebo

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:

  • 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 Mania Rating Scale (YMRS) score of less than 10 at screening visit
  • No acute episodes of depression or mania for the previous 12 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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Massachusetts General Hospital
Investigators
Principal Investigator: Dan V. Iosifescu, MD Icahn School of Medicine at Mount Sinai & Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Dan V. Iosifescu, M.D., M.Sc., Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00741598     History of Changes
Other Study ID Numbers: GCO 10-1060, R01MH079157, 1R01 MH079157-01A2, DATR A5-ETMA
Study First Received: August 25, 2008
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014