Phase 3
N=39
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Major Depression · Bipolar Depression · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00566735 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Number of Side Effects — 19; 13 Number of reported side effects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Razadyne (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Side Effects |
19; 13 | — |
| SECONDARY Cognitive Functioning |
80.33; 88.75; 68.50; 88.17 | <0.05 sig |
| SECONDARY Baseline Depressive Symptoms |
24.53; 27.33 | — |
Summary
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00566735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.