A Pilot Study - Ziprasidone used as an Adjunctive Therapy in patients with Major Depressive Disorder: Impact on Symptoms and Functional Disability

Phase 3

• Conditions: Mental Health - Depression; Major Depressive Disorder

• Registration Number: ACTRN12607000571471
• Lead Sponsor: Dr Nitin Dharwadkar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Patients with a diagnosis of Major Depressive Disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
2. Aged 18 to 55 years old
3. A history during the current depressive episode of an incomplete or partial response to a trial of a selective serotonin reuptake inhibitors antidepressant (SSRIs), or a noradrenergic and specific serotonergic antidepressant (NASSA), at an adequate dose for a minimum of 6 weeks.

Exclusion Criteria

1. Pregnancy
2. Lactation
3. Severe or unstable medical condition
5. Co-morbid diagnosis of any primary psychotic disorder or Personality Disorder
6. Co-morbid diagnosis of alcohol/substance abuse
7. Unable to obtain written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A > 20% change in score on the Hamilton Depression Rating Scale (HAMD-17), from baseline to week 6.[At baseline, and at 2,4 and 6 weeks after intervention commencement.];A reduction in the Clinical Global Impression Scale (CGI) score by at least 1 point, from baseline to week 6.[At baseline, and at 2,4 and 6 weeks after intervention commencement.]

Secondary Outcome Measures

Name	Time	Method
/A[N/A]