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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Massachusetts General Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital Identifier:
First received: May 4, 2010
Last updated: July 24, 2014
Last verified: July 2014

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
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) ]

Secondary Outcome Measures:
  • Time to response/remission [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
  • Number of ECT treatments to response/remission [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]

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


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01312844

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02144
Contact: John Matthews, M.D.   
Sponsors and Collaborators
Massachusetts General Hospital
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

Responsible Party: John D. Matthews, Principal Investigator, Assistant Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital Identifier: NCT01312844     History of Changes
Other Study ID Numbers: 2009P002288
Study First Received: May 4, 2010
Last Updated: July 24, 2014

Additional relevant MeSH terms:
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics processed this record on March 23, 2017