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

This study has been terminated.
(This was an inpatient study, but PI left inpatient service at MGH)
Sponsor:
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01312844
First received: May 4, 2010
Last updated: March 6, 2017
Last verified: March 2017
  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 Phase
Depression
Drug: Scopolamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:
  • Change in Ham D 17 Scores [ Time Frame: At the time of ECT completion (about 2 weeks) ]
    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.

  • Time to Response for Patients Receiving ECT [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
    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. .

  • Number of ECT Treatments Received to Achieve Response/Remission [ Time Frame: Duration of ECTtreatment (usually 2 weeks) ]
    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.


Secondary Outcome Measures:
  • Number of ECT Treatments Withheld Due to Cognitive Impairment [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
    The number of ECT treatments withheld during the course of the study due to cognitive impairment. In these cases, the participant would still be enrolled in the study but have a reduced # of ECTs. This outcome measure does not include patients who withdrew from the study.

  • The Mean Number of Moderate to Severe Side Effects [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
    The mean number of adverse events classified as moderate to severe.

  • The Mean Levels of Physiological Measures of ECT (Blood Pressure) [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
    blood pressure taken immediately post ECT treatment

  • The Mean Levels of Physiological Measures of ECT (Heart Rate) [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
    Heart rate taken immediately post ECT treatment

  • The Mean Levels of Physiological Measures of ECT (Seizure Duration) [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
    Duration of the seizure induced by ECT.

  • The Mean Levels of Physiological Measures of ECT (Energy Needed) [ Time Frame: Duration of ECT treatment (usually 2 weeks) ]
    Energy needed to induce the seizure


Enrollment: 7
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (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 at ECT treatment
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   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier: NCT01312844

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
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

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
Results First Received: February 8, 2017
Last Updated: March 6, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics

ClinicalTrials.gov processed this record on April 28, 2017