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

NCT00741598 | Completed Phase 4 Results DMC

• 4 other identifiers: GCO 10-1060R01MH0791571R01MH079157-01A2DATR A5-ETMA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  Measured at screening and 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

  Measured at screening and 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)

  Measured at screening; baseline; and Weeks 4, 8, 12, and 16

Secondary Outcomes (2)

• The Range of Impaired Functioning Tool (LIFE-RIFT)

  Baseline, Weeks 4, 8, 12, and 16

• Quality of Life Satisfaction Questionnaire (Q-LES-Q)

  Screening

Study Arms (2)

Galantamine-ER

EXPERIMENTAL

Participants will receive treatment with extended release galantamine

Drug: Galantamine-ER

Galantamine placebo

PLACEBO COMPARATOR

Participants will receive treatment with placebo.

Drug: Galantamine placebo

Interventions

Galantamine-ER DRUG

Galantamine-ER 8 to 24 mg per day for 16 weeks

Also known as: Razadyne-ER

Galantamine-ER

Galantamine placebo DRUG

Galantamine placebo 8 to 24 mg per day for 16 weeks

Also known as: placebo

Galantamine placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Links

• Click here for more information on the Massachusetts General Hospital's Bipolar Clinic and Research Program.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Dan V. Iosifescu
• Organization: Mood and Anxiety Disorders Program, Icahn School of Medicine at Mount Sinai

dan.iosifescu@mssm.edu

212-241-4480

Study Officials

• Dan V. Iosifescu, MD

  Icahn School of Medicine at Mount Sinai & Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc.

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 2, 2017
• Results First Posted: May 2, 2017

Record last verified: 2017-03

Locations

US (2)