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

NCT ID: NCT00566735

Last Updated: 2012-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-01-31

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).

Detailed Description

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Conditions

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Major Depression Bipolar Depression Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 mg, 2 times a day

2, Galantamine

Group Type ACTIVE_COMPARATOR

Razadyne

Intervention Type DRUG

The starting dose of study medication is 4 mg twice a day

Interventions

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Razadyne

The starting dose of study medication is 4 mg twice a day

Intervention Type DRUG

Placebo

4 mg, 2 times a day

Intervention Type DRUG

Other Intervention Names

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Galantamine

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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John D. Matthews

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John D Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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GAL-EMR-4005

Identifier Type: OTHER

Identifier Source: secondary_id

2004-P-001051

Identifier Type: -

Identifier Source: org_study_id