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

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Butylscopolammonium Bromide; Scopolamine; Scopolamine Hydrobromide

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