The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Bipolar Depression; Schizoaffective Disorder, Depressed Type
Intervention: Razadyne (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
John D Matthews, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Summary
The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat
problems with thinking and memory caused by electroconvulsive therapy (ECT).
Clinical Details
Official title: The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Primary outcome: Provide evidence for the tolerability of galantamine during ECT.
Secondary outcome: Assess the ability of galantamine to protect patients from the cognitive side effects of ECT, especially memory deficits.Evaluate the hypothesis that galantamine may enhance or quicken the anti-depressant action of ECT. Assess the post ECT impact of galantamine on depression and cognitive functioning at 1-month post discharge from the hospital
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Criteria to enter the study include males and females between the ages of 18-90
(females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder,
Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type,
or Schizoaffective Disorder, depressed type (19).
Exclusion Criteria:
- DSM-IV diagnoses of dementia and its subtypes
- Substance use disorder (active use within the last 6 months)
- Organic mental disorders; seizure disorder
- Unstable physical disorder or physical disorder judged to significantly affect the
central nervous system function
- A heart rate of <60
- A systolic blood pressure < 90
- Heart block
- Pre-existing sick-sinus
- Chronic treatment with beta blockers
- Any cardiac arrythmia
- Hypotension
- Coronary artery disease
- Liver and renal function impairment
- Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD
- Treatment with anti-cholinergic and cholinomimetic medications; and
- Female patients who are pregnant.
- Additionally, women subjects must be postmenopausal, surgically sterile, or using
prescription oral contraceptives (e. g. estrogen-progestin combinations) ,
contraceptive implants (e. g. NorplantTM, DepoProveraTM ), or transdermally delivered
contraceptives (Ortho EvraTM) before entry and throughout the study; and have a
negative serum b-HCG pregnancy test at screening.
Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in
this study.
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: July 2004
Ending date: January 2008
Last updated: December 3, 2007
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