CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Olanzapine/Zyprexadrug
Likely dose
Olanzapine 2.5–10 mg/day initial, titrated by 2.5–5 mg/day daily, maximum 20 mg/dayAI-extracted
Key inclusion· 5
  • ✓Age 18–70 years
  • ✓DSM-IV diagnosis of bipolar I, bipolar II, cyclothymic disorder, or bipolar disorder NOS with acute exacerbation (hypomania, depression, subsyndromal depression, or mixed) verified by SCID-I/P
  • ✓CGI-BP Overall Severity score ≥4 (mildly ill or worse)
  • ✓On stable prior medications for ≥2 weeks (≥6 weeks if fluoxetine) immediately before study entry
Key exclusion· 15
  • ✕Pregnant, nursing, or planning pregnancy during study
  • ✕Serious, unstable medical illness (hepatic, renal, gastroenterologic, respiratory, cardiovascular including ischemic heart disease, endocrinologic, neurologic, immunologic, or hematologic) requiring anticipated hospitalization within 3 months or death within 3 years
  • ✕History of seizure disorder
  • ✕History of leukopenia without clear, resolved etiology

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

Search/NCT00186017
NCT00186017Phase 4Completed
CompareCT.gov

Double-Blind Placebo-Controlled Olanzapine Add-on Therapy in the Treatment of Acute Syndromal and Subsyndromal Exacerbations in Bipolar Disorders

Stanford University·interventional·Posted Sep 16, 2005·Updated May 16, 2017

In Brief

A Phase 4 clinical trial evaluating Olanzapine/Zyprexa for Bipolar Disorder. Completed, enrolled 50 participants across 1 site.

Detailed Summary

We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study. We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will assess the effect of olanzapine on Young Mania Rating Scale (YMRS), Hamilton and Montgomery-Asberg Depression Rating Scales (HDRS, and MADRS), and Hamilton Anxiety Rating Scales (HARS) in the above paradigms. We will also assess the influence of presentation severity (CGI-S) and polarity (mood elevation versus depression) on olanzapine response. Finally, we will assess safety and tolerability of olanzapine in the above paradigms. We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in outpatients, randomized double-blind flexibly dosed olanzapine added to prior treatment (including no treatment) will yield greater CGI-S improvement than placebo by the end of one week, and that such improvement will persist over one week of open continuation treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJul 1, 2005
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.8 years ago

Interventions

Olanzapine/Zyprexadrug

Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.