Full Text View
Tabular View
No Study Results Posted
Related Studies
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
This study has been completed.
Study NCT00566735   Information provided by Massachusetts General Hospital
First Received: December 3, 2007   Last Updated: August 18, 2009   History of Changes

December 3, 2007
August 18, 2009
July 2004
 
Provide evidence for the tolerability of galantamine during ECT. [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00566735 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning

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).

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
  • Major Depression
  • Bipolar Depression
  • Schizoaffective Disorder, Depressed Type
  • Drug: Razadyne
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
44
January 2008
 

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.

Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566735
Jennie Vosk Project Manager, Vosk Consulting on belf of Ortho-McNeil Janssen Scientific Affairs LLC
2004-P-001051, GAL-EMR-4005
Massachusetts General Hospital
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: John D Matthews, MD Massachusetts General Hospital
Massachusetts General Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP