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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Galantamine

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.