Back to resultsEfficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Galantamine-ER
Galantamine placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Galantamine-ER
Galantamine placebo
Arm Description
Participants will receive treatment with extended release galantamine
Participants will receive treatment with placebo.
Outcomes
Primary Outcome Measures
Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16
CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are:
CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16.
Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16
WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules.
The outcome measures presented are Total correct baseline = total correct card choices at baseline Total errors baseline = total erroneous card choices at baseline Total correct week 16 = total correct card choices at week 16 Total errors baseline = total erroneous card choices at week 16
The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
Conner's CPT (Conner's Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter "X". The person must refrain from clicking if they see the letter "X" presented. Clicking to the letter "X" is a commission error, not clicking to other letters are omission errors.
The outcome measures presented are Total number of errors = Total number of omission + commission errors This outcome measure is presented at each study visit (baseline, week 4, week 8, week 12, and week 16)
Secondary Outcome Measures
The Range of Impaired Functioning Tool (LIFE-RIFT)
The LIFE-RIFT is a brief measure of functional impairment. The total scale score is a sum of four items with range of scale from 0 to 26 (from no impairment to severe impairment).
Quality of Life Satisfaction Questionnaire (Q-LES-Q)
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.
The outcome measures presented are Q-LES-Q Total score = Sum of all scores from all 16 areas of functioning
Full Information
NCT ID
NCT00741598
First Posted
August 25, 2008
Last Updated
March 21, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH), Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00741598
Brief Title
Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder
Official Title
The Efficacy and Safety of Galantamine for Dysfunction in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH), Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Galantamine-ER
Arm Type
Experimental
Arm Description
Participants will receive treatment with extended release galantamine
Arm Title
Galantamine placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive treatment with placebo.
Intervention Type
Drug
Intervention Name(s)
Galantamine-ER
Other Intervention Name(s)
Razadyne-ER
Intervention Description
Galantamine-ER 8 to 24 mg per day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Galantamine placebo
Other Intervention Name(s)
placebo
Intervention Description
Galantamine placebo 8 to 24 mg per day for 16 weeks
Primary Outcome Measure Information:
Title
Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16
Description
CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are:
CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16.
Time Frame
Measured at screening and Week 16
Title
Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16
Description
WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules.
The outcome measures presented are Total correct baseline = total correct card choices at baseline Total errors baseline = total erroneous card choices at baseline Total correct week 16 = total correct card choices at week 16 Total errors baseline = total erroneous card choices at week 16
Time Frame
Measured at screening and Week 16
Title
The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
Description
Conner's CPT (Conner's Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter "X". The person must refrain from clicking if they see the letter "X" presented. Clicking to the letter "X" is a commission error, not clicking to other letters are omission errors.
The outcome measures presented are Total number of errors = Total number of omission + commission errors This outcome measure is presented at each study visit (baseline, week 4, week 8, week 12, and week 16)
Time Frame
Measured at screening; baseline; and Weeks 4, 8, 12, and 16
Secondary Outcome Measure Information:
Title
The Range of Impaired Functioning Tool (LIFE-RIFT)
Description
The LIFE-RIFT is a brief measure of functional impairment. The total scale score is a sum of four items with range of scale from 0 to 26 (from no impairment to severe impairment).
Time Frame
Baseline, Weeks 4, 8, 12, and 16
Title
Quality of Life Satisfaction Questionnaire (Q-LES-Q)
Description
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.
The outcome measures presented are Q-LES-Q Total score = Sum of all scores from all 16 areas of functioning
Time Frame
Screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan V. Iosifescu, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai & Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder
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