Status:
COMPLETED
Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if adding the study drug, ziprasidone, to an antidepressant medication helps improve symptoms of Major Depressive Disorder (MDD). We are studying the drug's effecti...
Detailed Description
The proposed study involves three phases. The first phase is an 8-week, open-label trial of an SSRI for MDD. Patients who do not experience sufficient symptom improvement following this open-label tri...
Eligibility Criteria
Inclusion
- Written informed consent.
- Men or women, 18-65 years of age.
- MDD, current, according to DSM-IV criteria and as diagnosed by the SCID- I/P during the screen and baseline visit of phase 1.
- A HAM-D-17 score \> 14 during the screen and baseline visit of phase 1.
Exclusion
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine
- Device, tubal ligation, or partner with vasectomy).
- Serious suicide or homicide risk, as assessed by evaluating clinician.
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
- History of multiple adverse drug reactions or allergy to the study drug.
- The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).
- Patients requiring excluded medications (see appendix 1 for details).
- Psychotic features in the current episode or a history of psychotic features.
- Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
- Any investigational psychotropic drug within the last 3 months.
- Have failed more than 3 adequate antidepressant trials during the current MDE. Some examples of adequate dosage of an antidepressant trial include either \> 150 mg of imipramine (or its tricyclic equivalent), \> 60 mg of phenelzine (or its monoamine oxidase inhibitor equivalent), \> 20 mg of fluoxetine (or its SSRI-equivalent), \> 150mg of bupropion, \> 300mg of trazodone (or nefazodone), \>75 mg of venlafaxine, \>60mg of duloxetine, or \> 15mg of mirtazapine. A trial of adequate duration was defined as one during which the patient was on any given antidepressant at an adequate dose for a minimum of 6 weeks.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00633399
Start Date
July 1 2008
End Date
March 1 2014
Last Update
July 3 2014
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Massachusetts General Hospital- Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114