The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning (Galantamine)
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|ClinicalTrials.gov Identifier: NCT00566735|
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : December 3, 2012
Last Update Posted : December 3, 2012
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Placebo Comparator: 1||
4 mg, 2 times a day
|Active Comparator: 2, Galantamine||
The starting dose of study medication is 4 mg twice a day
Other Name: Galantamine
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00566735
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||John D Matthews, MD||Massachusetts General Hospital|