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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00566735
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : December 3, 2012
Last Update Posted : December 3, 2012
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
John D. Matthews, 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).

Condition or disease Intervention/treatment Phase
Major Depression Bipolar Depression Schizoaffective Disorder Drug: Razadyne Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Study Start Date : July 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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 Name: Galantamine

Primary Outcome Measures :
  1. Number of Side Effects [ Time Frame: 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 :
  1. Cognitive Functioning [ Time Frame: 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.

  2. Baseline Depressive Symptoms [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00566735

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: John D Matthews, MD Massachusetts General Hospital

Responsible Party: John D. Matthews, Principal Investigator, Massachusetts General Hospital Identifier: NCT00566735     History of Changes
Other Study ID Numbers: 2004-P-001051
GAL-EMR-4005 ( Other Identifier: Janssen Pharmaceuticals )
First Posted: December 4, 2007    Key Record Dates
Results First Posted: December 3, 2012
Last Update Posted: December 3, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Psychotic Disorders
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents