A Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT)
Condition: Depression
MeSH terms: Depression
Intervention: Scopolamine
Intervention description: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

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.
    

Eligibility 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