Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD

• Status: Completed
• Trial end date: 2018-03-08
• Target enrollment: 0
• Participant gender: All

Summary

Despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Moreover, in those patients who do experience symptomatic relief following conventional anti-depressant treatment, clinical improvement is not evident for 3-4 weeks. Thus, there is a clear need to develop novel and improved therapeutics for unipolar depression.

A previous study showed that the intravenous administration of scopolamine produces antidepressant effects. This study is designed to determine if scopolamine combine with Escitalopram produce antidepressant effects at an early stage.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Treatments: Butylscopolammonium Bromide; Citalopram; Dexetimide; Scopolamine; Scopolamine Hydrobromide

Criteria

Inclusion Criteria:

1. Has given written informed consent.

2. Male or female outpatients aged at least 18 years and not more than 45 years.

3. Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.

4. Current HAMD-17 score ≥ 20 and the duration of the index episode is greater than or equal to four weeks.

Exclusion Criteria:

1. Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug.

2. Current Axis I primary psychiatric diagnosis other than major depressive disorder.

3. Organic mental disease, including mental retardation.

4. History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.

5. Subjects receiving an investigational agent (including different formulation and generic agents of investigational drug) in the previous 3 months prior to screening.

6. Women in pregnancy or lactation, or female of child bearing potential without appropriate birth control measures.

7. Use of antipsychotics or mood stabilizers within 5 days prior to screening.

8. Has received depot antipsychotic medication within one cycle prior to screening.

9. Known allergy or lack of response to mirtazapine.

10. Has received ECT or MECT within 3 months prior to screening.

11. History of anticholinergic drug allergy or complications (allergic reaction, skin rash, urticaria and other allergic reactions which caused by drugs).

12. Smokers.

13. Significant risk of suicidal and/or self-harm behaviors