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

This study is currently recruiting participants.
Verified November 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01312844
First received: May 4, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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. Patients receiving ECT plus scopolamine will have greater improvement in depression symptoms than those receiving ECT plus placebo.
  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. Time to response and to remission in the scopolamine group will be significantly shorter compared to ECT alone.

Condition Intervention
Depression
Drug: Scopolamine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Ham D 17 scores [ Time Frame: Duration of ECT treatment (on average, 2 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to response/remission [ Time Frame: Duration of ECT treatment (usually 2 weeks) ] [ Designated as safety issue: No ]
  • Number of ECT treatments to response/remission [ Time Frame: Duration of ECT treatment (usually 2 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scopolamine
Patients receiving IV scopolamine at ECT treatment
Drug: Scopolamine
Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Placebo Comparator: Placebo
Patients receiving IV placebo
Drug: Scopolamine
Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Substance use disorder active use within the last 6 months (per assessment using SCID)
  2. Organic mental disorders
  3. Seizure disorders
  4. Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
  5. Heart block
  6. Pre-existing sick-sinus
  7. Chronic treatment with beta blockers
  8. Any cardiac arrhythmia
  9. Hypotension
  10. Coronary artery disease
  11. Liver and renal function impairment
  12. Urge incontinence or prostatic hypertrophy
  13. Colitis
  14. Crohn's disease
  15. GI motility disorders
  16. Asthma
  17. COPD
  18. Treatment with anti-cholinergic and cholinomimetic medications
  19. Contraindications to scopolamine including hypersensitivity to scopolamine, other belladonna alkaloids, and/or any component of the formulation
  20. Wide and narrow angle glaucoma
  21. Acute hemorrhage
  22. Paralytic ileus
  23. Myasthenia gravis
  24. Patients on belladonna, belladonna alkaloids, cisapride, or potassium chloride
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312844

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02144
Contact: John Matthews, M.D.       jmatthews@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John D Matthews, MD Massachusetts General Hospital
Principal Investigator: David Abramson, MD Massachusetts General Hospital
Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: John D. Matthews, Principal Investigator, Assistant Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01312844     History of Changes
Other Study ID Numbers: 2009P002288
Study First Received: May 4, 2010
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Scopolamine
Butylscopolammonium Bromide
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Parasympatholytics

ClinicalTrials.gov processed this record on April 20, 2014