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

Primary Purpose

Major Depression, Bipolar Depression, Schizoaffective Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Razadyne

Placebo

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2, Galantamine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00566735

First Posted

December 3, 2007

Last Updated

November 2, 2012

Sponsor

Massachusetts General Hospital

Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00566735

Brief Title

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

Acronym

Galantamine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression, Bipolar Depression, Schizoaffective Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

2, Galantamine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Razadyne

Other Intervention Name(s)

Galantamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

4 mg, 2 times a day

Primary Outcome Measure Information:

Title

Number of Side Effects

Description

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.

Time Frame

Participants were followed for the duration of hospital stay, an average of 3 weeks

Secondary Outcome Measure Information:

Title

Cognitive Functioning

Description

Time Frame

Participants were questioned at baseline and after their last electroconvulsive therapy treatment

Title

Baseline Depressive Symptoms

Description

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.

Time Frame

Participants were questioned at baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D Matthews, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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