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Completed

NCT Number: NCT00566735

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Razadyne

Drug

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

Other names: Galantamine

Placebo

Drug

4 mg, 2 times a day

Primary outcomes

  1. Number of Side Effects

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

    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 outcomes

  1. Cognitive Functioning

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

    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.

  2. Baseline Depressive Symptoms

    Time frame: Participants were questioned at baseline

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

Registry information

Acronym: Galantamine

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Dec 4, 2007
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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