The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
This study has been completed.
Sponsor:
Massachusetts General Hospital
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
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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
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 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 May 23, 2013