A Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT)

NCT01312844 | Terminated Phase 2 Results

• 1 other identifier: 2009P002288
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to assess the ability of scopolamine to improve the antidepressant effects of ECT and to determine whether scopolamine will shorten the time to response and remission for patients receiving ECT. The hypothesis are:

1. 1.Patients receiving ECT plus scopolamine will have greater improvement in depression symptoms than those receiving ECT plus placebo.
2. 2.Patients receiving scopolamine in addition to ECT will require fewer ECT treatments to obtain response/remission compared to the group receiving ECT plus placebo.
3. 3.Time to response and to remission in the scopolamine group will be significantly shorter compared to ECT alone.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Change in Ham D 17 Scores

  Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score.

  At the time of ECT completion (about 2 weeks)

• Time to Response for Patients Receiving ECT

  The number of days between baseline HAM D score and HAM D score showing response (defined as a HAM D score less than half of baseline). If patients HAM D score rose above this marker at any point in the study, they were not considered as responding.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. .

  Duration of ECT treatment (usually 2 weeks)

• Number of ECT Treatments Received to Achieve Response/Remission

  The number of ECT treatments needed to achieve response (defined as a HAM D score less than half of baseline) and remission (defined as a HAM D score of less than 8). If patients HAM D score rose above these markers at any point in the study, they were not considered as responding or remitting.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression.

  Duration of ECTtreatment (usually 2 weeks)

Secondary Outcomes (6)

• Number of ECT Treatments Withheld Due to Cognitive Impairment

  Duration of ECT treatment (usually 2 weeks)

• The Mean Number of Moderate to Severe Side Effects

  Duration of ECT treatment (usually 2 weeks)

• The Mean Levels of Physiological Measures of ECT (Blood Pressure)

  Duration of ECT treatment (usually 2 weeks)

• The Mean Levels of Physiological Measures of ECT (Heart Rate)

  Duration of ECT treatment (usually 2 weeks)

• The Mean Levels of Physiological Measures of ECT (Seizure Duration)

  Duration of ECT treatment (usually 2 weeks)

Study Arms (2)

Scopolamine

EXPERIMENTAL

Patients receiving IV scopolamine at ECT treatment

Drug: Scopolamine

Placebo

PLACEBO COMPARATOR

Patients receiving IV placebo at ECT treatment

Drug: Scopolamine

Interventions

Scopolamine DRUG

Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT

Placebo; Scopolamine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females between the ages of 18-50 (inclusive)
• DSM-IV diagnosis of Major Depressive Disorder (MDD), without psychotic features, and a HAM-D-17 score of 18 or higher
• Female subjects must be postmenopausal, surgically sterile, or, if of child-bearing age, using double-barrier contraceptive method or 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 urine b-HCG pregnancy test at screening.

You may not qualify if:

• Substance use disorder active use within the last 6 months (per assessment using SCID)
• Organic mental disorders
• Seizure disorders
• Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
• Heart block
• Pre-existing sick-sinus
• Chronic treatment with beta blockers
• Any cardiac arrhythmia
• Hypotension
• Coronary artery disease
• Liver and renal function impairment
• Urge incontinence or prostatic hypertrophy
• Colitis
• Crohn's disease
• GI motility disorders

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Scopolamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Dr. John Matthews
• Organization: Massachusetts General Hospital

jmatthews@partners.org

617-643-9095

Study Officials

• John D Matthews, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• David Abramson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Maurizio Fava, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: March 11, 2011
• Study Start: April 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 30, 2017
• Results First Posted: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)