NCT00050206

Brief Summary

The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

June 12, 2007

Status Verified

June 1, 2007

First QC Date

November 26, 2002

Last Update Submit

June 11, 2007

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents

Secondary Outcomes (4)

  • Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)

  • Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).

  • Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.

  • Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment

Interventions

OlanzapineDRUG
PlaceboDRUG

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
  • Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
  • Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.

You may not qualify if:

  • Female patients who are either pregnant or nursing.
  • Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
  • Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
  • Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
  • Patients who have been judged clinically to be serious suicidal risks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 hrs, EST), or speak with your personal physician.

Indianapolis, Indiana, United States

Location

Related Publications (3)

  • Xiao L, Ganocy SJ, Findling RL, Chang K, DelBello MP, Kane JM, Tohen M, Xiang YT, Correll CU. Baseline Characteristics and Early Response at Week 1 Predict Treatment Outcome in Adolescents With Bipolar Manic or Mixed Episode Treated With Olanzapine: Results From a 3-Week, Randomized, Placebo-Controlled Trial. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1158-e1166. doi: 10.4088/JCP.16m10923.

    PMID: 28922591DERIVED

  • Kryzhanovskaya LA, Robertson-Plouch CK, Xu W, Carlson JL, Merida KM, Dittmann RW. The safety of olanzapine in adolescents with schizophrenia or bipolar I disorder: a pooled analysis of 4 clinical trials. J Clin Psychiatry. 2009 Feb;70(2):247-58. doi: 10.4088/jcp.08m03538. Epub 2009 Feb 10.

    PMID: 19210948DERIVED

  • Tohen M, Kryzhanovskaya L, Carlson G, Delbello M, Wozniak J, Kowatch R, Wagner K, Findling R, Lin D, Robertson-Plouch C, Xu W, Dittmann RW, Biederman J. Olanzapine versus placebo in the treatment of adolescents with bipolar mania. Am J Psychiatry. 2007 Oct;164(10):1547-56. doi: 10.1176/appi.ajp.2007.06111932.

    PMID: 17898346DERIVED

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

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

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 26, 2002

First Posted

November 27, 2002

Study Start

November 1, 2002

Study Completion

May 1, 2005

Last Updated

June 12, 2007

Record last verified: 2007-06

Locations

US(1)