The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depression, Bipolar Depression, Schizoaffective Disorder

In brief

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).

Key facts

Study ID

NCT00566735

Run by

Massachusetts General Hospital

People needed

39

Starts

2004-07-01

Expected to finish

2008-01-01

Last updated by the study team

2012-12-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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