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

Study Overview
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Brief Summary
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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).

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

Conditions
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Major Depression, Bipolar Depression, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Razadyne
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* 4 mg, 2 times a day<br>|
| Active Comparator: 2, Galantamine<br> | Drug: Razadyne<br>* The starting dose of study medication is 4 mg twice a day<br>* Other names: Galantamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Side Effects | 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. | Participants were followed for the duration of hospital stay, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Functioning | 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. | Participants were questioned at baseline and after their last electroconvulsive therapy treatment | 
| Baseline Depressive Symptoms | 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. | Participants were questioned at baseline |