Short Term Rescue Study of Olanzapine

NCT00186017 | Completed Phase 4 Results

• 2 other identifiers: 79897F1D-US-X279
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Mean Change in CGI-BP-OS After 1 Week of Treatment

  The Clinical Global Impression - bipolar version - overall severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not ill; 2, minimally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, very severely ill

  Baseline, 1 Week

Secondary Outcomes (3)

• Mean Change in YMRS After 1 Week of Treatment

  Baseline, 1 week

• Mean Change in MADRS After 1 Week of Treatment.

  Baseline, 1 week

• Mean Change in Hamilton Anxiety Rating Scales (HAM-A)

  Baseline, 1 Week

Study Arms (2)

Olanzapine/Zyprexa

EXPERIMENTAL

Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week

Drug: Olanzapine/Zyprexa

Placebo

PLACEBO COMPARATOR

Placebo was taken in the same manner as olanzapine with up to 8 per day for 1 week

Drug: Olanzapine/Zyprexa

Interventions

Olanzapine/Zyprexa DRUG

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.

Also known as: Zyprexa

Olanzapine/Zyprexa; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients, 18 to 70 years of age
• Female patients of childbearing potential must be using a medically accepted means of contraception
• Able to communicate intelligently with the investigator, and study coordinator
• Able to give informed consent
• DSM-IV diagnosis of bipolar I, bipolar II, cyclothymic disorder or bipolar disorder not otherwise specified, experiencing an acute exacerbation of their illness at Visit 1 (hypomania, subsyndromal depression, hypomania and subsyndromal depression, depression and hypomania, or depression if diagnosed with bipolar II) as verified by SCID-I/P
• CGI-BP Overall Severity score greater than or equal to mildly ill at Visit 1

You may not qualify if:

• Pregnant, nursing, or intending to become pregnant during the study
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within 3 months or death is anticipated within 3 years.
• A history of seizure disorder
• History of leukopenia without a clear and resolved etiology.
• DSM-IV substance (except nicotine or caffeine) dependence within the past month
• Judged clinically to be at serious suicidal risk
• Participation in clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
• Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to study entry
• Treatment resistance, non-response, or intolerability with olanzapine by the investigator's judgment
• Treatment with clozapine within 3 months prior to study entry
• Treatment with remoxipride within 6 months (180 days) prior to study entry
• Treatment with an oral antipsychotic within 2 days prior to study entry
• A course of ECT (electroconvulsive therapy) in the preceding 4 weeks
• Excluded mood symptoms noted in Table 1 \[of protocol\]
• Unstable thyroid pathology and treatment-initiated or altered within the past 3 months

Sponsors & Collaborators

• Stanford University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Links

• Stanford University Bipolar Disorders Clinic

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Small Sample Size.

Results Point of Contact

• Title: Dr. Terence A. Ketter, MD.
• Organization: Stanford University School of Medicine

tketter@stanford.edu

6507232507

Study Officials

• Terence Arthur Ketter

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)