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

Phase 3

Completed

• Conditions: Major Depression; Bipolar Depression; Schizoaffective Disorder
• Interventions: Drug: Placebo; Drug: Razadyne

• Registration Number: NCT00566735
• Lead Sponsor: Massachusetts General Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2012-06-05
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-02
• Last Update Submitted: 2012-11-02
• Results First Posted: 2012-12-03
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2, Galantamine	Razadyne	-

Primary Outcome Measures

Name	Time	Method
Number of Side Effects	Participants were followed for the duration of hospital stay, an average of 3 weeks	This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.

Secondary Outcome Measures

Name	Time	Method
Cognitive Functioning	Participants were questioned at baseline and after their last electroconvulsive therapy treatment	This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.
Baseline Depressive Symptoms	Participants were questioned at baseline	This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with \<7 referring to mild-to-no depression, and \>23 referring to severe depression.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States