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

This study has been completed.

First Received on December 3, 2007. Last Updated on August 18, 2009 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborator:	Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00566735

Purpose

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).

Condition	Intervention	Phase
Major Depression Bipolar Depression Schizoaffective Disorder, Depressed Type	Drug: Razadyne Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning

Resource links provided by NLM:

MedlinePlus related topics: Depression Memory

Drug Information available for: Galantamine hydrobromide Galantamine

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Provide evidence for the tolerability of galantamine during ECT. [ Time Frame: Study Duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the ability of galantamine to protect patients from the cognitive side effects of ECT, especially memory deficits. [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
Evaluate the hypothesis that galantamine may enhance or quicken the anti-depressant action of ECT. [ Time Frame: Study Duration ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	July 2004
Study Completion Date:	January 2008

Arms	Assigned Interventions
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 Name: Galantamine

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566735

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

Principal Investigator:

John D Matthews, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Jennie Vosk Project Manager, Vosk Consulting on belf of Ortho-McNeil Janssen Scientific Affairs LLC
ClinicalTrials.gov Identifier:	NCT00566735 History of Changes
Other Study ID Numbers:	2004-P-001051, GAL-EMR-4005
Study First Received:	December 3, 2007
Last Updated:	August 18, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Psychotic Disorders
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Galantamine
Parasympathomimetics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012