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

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: Razadyne
  • The starting dose of study medication is 4 mg twice a day
• Drug: Placebo
  • 4 mg, 2 times a day

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Active Comparator: 2, Galantamine

Primary Measures

• Provide evidence for the tolerability of galantamine during ECT.
  • Time Frame: Study Duration
    Safety Issue?: No

Secondary Measures

• Assess the ability of galantamine to protect patients from the cognitive side effects of ECT, especially memory deficits.
  • Time Frame: Study Duration
    Safety Issue?: No
• Evaluate the hypothesis that galantamine may enhance or quicken the anti-depressant action of ECT.
  • Time Frame: Study Duration
    Safety Issue?: No
• Assess the post ECT impact of galantamine on depression and cognitive functioning at 1-month post discharge from the hospital
  • Time Frame: Last Month of Study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

John D Matthews, MD Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00566735

Study ID Number: 2004-P-001051

ClinicalTrials.gov Identifier: NCT00566735

Health Authority: United States: Institutional Review Board