Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Ziprasidone; Placebo
Intervention description: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.; 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
Intervention MeSH terms: Ziprasidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 458.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Major Depression; Depression; Geodon; Ziprasidone; SSRI Augmentation; Treatment Resistant Depression

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.