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

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Major Depression; Schizoaffective Disorder; Bipolar Depression

Treatments: Drug: Placebo; Drug: Razadyne

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00566735

2004-P-001051

GAL-EMR-4005 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 39 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2, Galantamine

Active Comparator group

Treatment:

Drug: Razadyne