Phase 2
Completed N=139
Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs
Source: ClinicalTrials.gov NCT00633399 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2 — 35.2; 20.5 Percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2 |
35.2; 20.5 | — |
| SECONDARY Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2. |
38; 30 | — |
| SECONDARY Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8 |
-6.4; -3.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00633399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.