| 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
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| Completed |
| 44 |
| January 2008 |
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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. |
| 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 |
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| Massachusetts General Hospital |
| August 2009 |