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

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00566735
First received: December 3, 2007
Last updated: November 2, 2012
Last verified: November 2012
  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
Drug: Razadyne
Drug: Placebo
Phase 3

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:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Side Effects [ Time Frame: Participants were followed for the duration of hospital stay, an average of 3 weeks ] [ Designated as safety issue: No ]
    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:
  • Cognitive Functioning [ Time Frame: Participants were questioned at baseline and after their last electroconvulsive therapy treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants were questioned at baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: July 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: John D. Matthews, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00566735     History of Changes
Other Study ID Numbers: 2004-P-001051, GAL-EMR-4005
Study First Received: December 3, 2007
Results First Received: June 5, 2012
Last Updated: November 2, 2012
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
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014