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

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 Overview

• Status: Completed
• Conditions: Schizoaffective Disorder; Major Depression; Bipolar Depression
• Intervention / Treatment: Drug: Placebo; Drug: Razadyne

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1	Drug: Placebo; 4 mg, 2 times a day
Active Comparator: 2, Galantamine	Drug: Razadyne; The starting dose of study medication is 4 mg twice a day; Other Names: Galantamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Side Effects	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.	Participants were followed for the duration of hospital stay, an average of 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Functioning	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.	Participants were questioned at baseline and after their last electroconvulsive therapy treatment
Baseline Depressive Symptoms	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.	Participants were questioned at baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Ortho-McNeil Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: December 3, 2007
• First Submitted That Met QC Criteria: December 3, 2007
• First Posted (Estimate): December 4, 2007

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 2, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Psychotic Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Galantamine
• Other Study ID Numbers: 2004-P-001051; GAL-EMR-4005 (Other Identifier: Janssen Pharmaceuticals)