CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Ziprasidone/Geodondrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Bipolar Disorder Type I, II, or NOS on ongoing atypical antipsychotic(s) and/or mood stabilizer(s) known to cause weight gain (lithium, valproate, olanzapine, risperidone, quetiapine, aripiprazole)
  • ✓Age 18–65 years
  • ✓BMI ≥30 kg/m² OR BMI ≥27 kg/m² with metabolic abnormalities (fasting cholesterol ≥200 mg/dL, triglycerides ≥250 mg/dL, or glucose ≥100 mg/dL)
  • ✓Stable medication regimen for at least one month
Key exclusion· 10
  • ✕DSM-IV Axis I diagnoses: delirium, dementia, cognitive disorders, schizophrenia, anorexia nervosa, bulimia, or active substance abuse/dependence or illicit drug use (excluding marijuana) within past month
  • ✕Antisocial personality disorder
  • ✕Medical complications of obesity (diabetes, hypertension, hyperlipidemia, cardiovascular disease) unless managed by own physician who authorizes participation and adjusts concurrent medications
  • ✕MADRS Item 10 (Suicidal Thoughts) ≥4

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00472641
NCT00472641Phase 4Completed
CompareCT.gov

Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder

Stanford University·interventional·Posted May 14, 2007·Updated May 9, 2017

In Brief

A Phase 4 clinical trial evaluating Ziprasidone/Geodon for Bipolar Disorder. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese patients with bipolar disorder. There will be approximately 25 patients enrolled in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 14, 2007
Enrollment StartJan 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.1 years ago

Interventions

Ziprasidone/Geodondrug

Ziprasidone/Geodon