A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

NCT00402324 | Completed Phase 4 Results

• 2 other identifiers: 10825F1D-US-HGMO
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.

Conditions

Bipolar I Disorder

Keywords

Mixed episode associated with Bipolar I

Outcome Measures

Primary Outcomes (2)

• Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.

  The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  Baseline to endpoint (6 weeks)

• Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.

  The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.

  Baseline to endpoint (6 weeks)

Secondary Outcomes (11)

• Number of Participants Meeting the Criteria for Mixed Onset of Action

  Baseline to endpoint (6 weeks)

• Number of Participants Meeting the Criteria for Mixed Response

  baseline to endpoint (6 weeks)

• Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint

  Baseline to endpoint (6 weeks)

• Number of Patients Hospitalized Due to Relapse of Mania or Depression.

  Baseline to endpoint (6 weeks)

• Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline

  Baseline to endpoint (6 weeks)

Study Arms (2)

1

EXPERIMENTAL

olanzapine and divalproex

Drug: olanzapine; Drug: divalproex

2

PLACEBO COMPARATOR

placebo and divalproex

Drug: placebo; Drug: divalproex

Interventions

olanzapine DRUG

15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).

Also known as: LY170053, Zyprexa

1

placebo DRUG

placebo, capsules, by mouth every evening, daily, for 6 weeks.

2

divalproex DRUG

dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).

1; 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with a mixed episode of bipolar I disorder.
• Have had at least one previous manic or mixed episode associated with bipolar disorder
• You must be between 18 and 60 years old.
• You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.
• If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.

You may not qualify if:

• You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.
• You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.
• Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).
• You are allergic to any of the medications involved in this study.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hialeah, Florida, 33016, United States

Location

Related Publications (2)

• Houston JP, Gatz JL, Degenhardt EK, Jamal HH. Symptoms predicting remission after divalproex augmentation with olanzapine in partially nonresponsive patients experiencing mixed bipolar I episode: a post-hoc analysis of a randomized controlled study. BMC Res Notes. 2010 Nov 2;3:276. doi: 10.1186/1756-0500-3-276.

  PMID: 21044339 DERIVED

• Houston JP, Tohen M, Degenhardt EK, Jamal HH, Liu LL, Ketter TA. Olanzapine-divalproex combination versus divalproex monotherapy in the treatment of bipolar mixed episodes: a double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Nov;70(11):1540-7. doi: 10.4088/JCP.08m04895yel. Epub 2009 Sep 22.

  PMID: 19778495 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Interventions

Olanzapine; Valproic Acid

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: December 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 3, 2009
• Results First Posted: May 27, 2009

Record last verified: 2009-05

Locations

US (1)