Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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 effectiveness in treating depression, as well as its safety when it is added to another drug. Hypothesis A: There will be a difference in the percentage of responders in the two treatment conditions during phase 2; response rates will be higher for the ziprasidone group.

Key facts

Study ID

NCT00633399

Run by

Massachusetts General Hospital

People needed

458

Starts

2008-07-01

Expected to finish

2014-03-01

Last updated by the study team

2014-07-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Massachusetts General Hospital- Depression Clinical and Research Program — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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