None listed
Conditions
Brief summary
This study is a 6-week, naturalistic open-label evaluation of the efficacy and tolerability of ziprasidone hydrochloride (20mg/day to 80mg/day), in combination with an antidepressant in the treatment of patients with major depressive disorder (MDD), and aims to assess the antidepressant effect of ziprasidone in conjunction with an antidepressant in treating patients who have shown an incomplete or partial response an antidepressant alone.
Interventions
The starting dose of 20mg oral Ziprasidone hydrochloride daily, will be gradually increased up to the maximum daily dose of 80mg for 3 weeks. During this time, the daily dose will be increased or decreased as required, based on the subject’s tolerability. Once established, the subject will remain on this stable dose for the remaining 3 weeks of the study.
Sponsors
Dr Nitin Dharwadkar
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Outcome results
None listed