A Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT01312844
- Run by
- Massachusetts General Hospital
- People needed
- 7
- Starts
- 2010-04-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2017-05-30
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
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
- Asthma
- COPD
- Treatment with anti-cholinergic and cholinomimetic medications
- Contraindications to scopolamine including hypersensitivity to scopolamine, other belladonna alkaloids, and/or any component of the formulation
- Wide and narrow angle glaucoma
- Acute hemorrhage
- Paralytic ileus
- Myasthenia gravis
- Patients on belladonna, belladonna alkaloids, cisapride, or potassium chloride
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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