Bipolar I DisorderPhase 4NCT00982020

Study in Adolescents With Schizophrenia or Bipolar Disorder

A Phase 4 study testing Olanzapine, Standard behavioral weight intervention and Intense behavioral weight intervention in people with Bipolar I Disorder and Schizophrenia, run by Eli Lilly and Company at 14 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia. Read more about this study

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Bipolar I Disorder, Schizophrenia
What is being tested?: Olanzapine, Standard behavioral weight intervention and Intense behavioral weight intervention
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 14 sitesin 4 countries
Study dates: Sep 2009to May 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participants must have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) or a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR)and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL).
Participants with a diagnosis of schizophrenia must obtain a Brief Psychiatric Rating Scale for Children (BPRS-C) total score >30, with a minimum score of 3 on at least one of the following items at both screening and randomization - hallucinations, delusions, peculiar fantasies.
Participants with a diagnosis of bipolar I disorder must have a Young Mania Rating Scale (YMRS) total score greater than or equal to 15 at both screening and randomization.
Has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit participant to perform all tests and examinations required by the protocol, and understands the nature of the study.

Who cannot join

History of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder.
Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to randomization.
Been judged clinically to be at any suicidal risk.
History of allergic reaction or hypersensitivity to olanzapine.
Receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program.
Other antipsychotics, mood stabilizers, or anticonvulsants (for mood stabilization) used for the primary study conditions (bipolar I disorder or schizophrenia)

Show all 20Show fewer

Have acute, serious, or unstable medical conditions
Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 12 months (365 days).
Have had one or more seizures without a clear and resolved etiology.
Baseline alanine aminotransferase (ALT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at screening.
Have leukopenia or history of leukopenia without a clear and resolved etiology or known history of agranulocytosis (absolute neutrophil count <500 cubic millimeter [mm^3], <0.5 GI/L, or <0.5 10E^3/microliters [μL]) during the participant's lifetime.
Prolactin level of >200 nanograms per milliliter (ng/mL) [>200 micrograms per liter (ug/L), or >4228 milli-International unit per liter (mIU/L)] at screening.
Have QTc (Bazett's) >450 milliseconds (males) or >460 milliseconds (females) at screening.
Previously been randomized in this study and/or participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to screening.
Currently prescribed olanzapine for greater than or equal to 5 days within 1 month (30 days) prior to screening.
Are investigator site personnel directly affiliated with this study and/or their immediate families OR are employed by or representatives of Lilly.
Pregnant or nursing.
Have received treatment within the last 30 days with an investigational new drug that has not received regulatory approval for any indication at the time of study entry.
Treatment with clozapine within 14 days prior to randomization.
Participants who have used olanzapine (that is, oral olanzapine, intramuscular [IM] olanzapine, or olanzapine orally disintegrating tablets) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, or who have exhibited a lack of efficacy/response to treatment to olanzapine including treatment resistance.

Trial locations and contacts

14 sites in 4 countries.

Country

City, postcode or hospital

14 sites in 4 countries

Russia5 sites

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.
Lipetsk, 399313
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.
Moscow, 115522
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.
Petrozavodsk, 185001
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.
Saint Petersburg, 192019
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.
Saratov, 410060

Other trials in Russia

United States4 sites

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.
Bellevue, Washington, 98007
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.
Bloomfield Hills, Michigan, 48302
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.
Lauderhill, Florida, 33319
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.
St Louis, Missouri, 63128

Other trials in United States

Poland3 sites

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.
Poznan, 60-792
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.
Torun, 87-100
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.
Wroclaw, 54-235

Other trials in Poland

Puerto Rico2 sites

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.
Caguas, 00725
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.
San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia

Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.

Conditions: Bipolar I Disorder, Schizophrenia
Being tested: Olanzapine, Standard behavioral weight intervention, Intense behavioral weight intervention
Keywords: safety, schizophrenia, bipolar I (manic or mixed), adolescents, weight management
Medical subject headings: Schizophrenia, Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlanzapineDrug
Also called Zyprexa, LY170053
2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks
Standard behavioral weight interventionBehavioural
One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.
Intense behavioral weight interventionBehavioural
Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.

Study groups in NCT00982020
Study group	Role	What they receive
Olanzapine/standard behavioral weight intervention	Experimental	Not described Receives: Drug: Olanzapine; Behavioral: Standard behavioral weight intervention
Olanzapine/intense behavioral weight intervention	Experimental	Not described Receives: Drug: Olanzapine; Behavioral: Intense behavioral weight intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
Measured: Baseline, 52 weeks

Secondary outcomes (7)

Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months
Measured: Baseline, 52 weeks
Time to Event for 7%, 15%, and 25% Weight Gain for All Participants
Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).
Measured: Baseline up to 52 weeks
Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder
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 (symptom not present) to 60 (symptom extremely severe).
Measured: Baseline, 52 weeks
Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants
The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).
Measured: 52 weeks
Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants
Measured: Baseline, 52 weeks
Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants
The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.
Measured: Baseline, 52 weeks
Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia
The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Measured: Baseline, 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009May 2013

First posted22 Sep 2009 (estimated)
Study startSep 2009
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00982020
Sponsor's protocol ID: 12117
Other IDs: F1D-MC-HGMX
Status last verified: Dec 2014
First submitted: 15 Sep 2009
Last updated: 17 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Detke HC, DelBello MP, Landry J, Hoffmann VP, Heinloth A, Dittmann RW. A 52-Week Study of Olanzapine with a Randomized Behavioral Weight Counseling Intervention in Adolescents with Schizophrenia or Bipolar I Disorder. J Child Adolesc Psychopharmacol. 2016 Dec;26(10):922-934. doi: 10.1089/cap.2016.0010. Epub 2016 Sep 27.
PubMed 27676420

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia
ClinicalTrials.gov ID: NCT00982020
Acronym / sponsor ID: 12117
Conditions: Bipolar I Disorder, Schizophrenia
Keywords: safety, schizophrenia, bipolar I (manic or mixed), adolescents, weight management
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 22 Sep 2009 (estimated)
Results: Posted 17 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Olanzapine/standard behavioral weight intervention	Experimental	Drug: Olanzapine, Behavioral: Standard behavioral weight intervention
Olanzapine/intense behavioral weight intervention	Experimental	Drug: Olanzapine, Behavioral: Intense behavioral weight intervention

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Participants must have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) or a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR)and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL).
Participants with a diagnosis of schizophrenia must obtain a Brief Psychiatric Rating Scale for Children (BPRS-C) total score >30, with a minimum score of 3 on at least one of the following items at both screening and randomization - hallucinations, delusions, peculiar fantasies.
Participants with a diagnosis of bipolar I disorder must have a Young Mania Rating Scale (YMRS) total score greater than or equal to 15 at both screening and randomization.
Has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit participant to perform all tests and examinations required by the protocol, and understands the nature of the study.

Key exclusion criteria (20 listed)

History of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder.
Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to randomization.
Been judged clinically to be at any suicidal risk.
History of allergic reaction or hypersensitivity to olanzapine.
Receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OlanzapineAlso: Zyprexa, LY1700532.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks	Drug	Olanzapine/intense behavioral weight intervention, Olanzapine/standard behavioral weight intervention
Standard behavioral weight interventionOne time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.	Behavioural	Olanzapine/standard behavioral weight intervention
Intense behavioral weight interventionCounseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.	Behavioural	Olanzapine/intense behavioral weight intervention

Primary outcome

Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
Time frame: Baseline, 52 weeks

7 secondary outcomes

Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months
Time frame: Baseline, 52 weeks
Time to Event for 7%, 15%, and 25% Weight Gain for All Participants
Time frame: Baseline up to 52 weeks
Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder
Time frame: Baseline, 52 weeks
Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants
Time frame: 52 weeks
Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants
Time frame: Baseline, 52 weeks
Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants
Time frame: Baseline, 52 weeks
Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia
Time frame: Baseline, 52 weeks

Results and safety

Results posted to the registry on 17 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olanzapine/Standard Behavioral Weight Intervention	102	45
Olanzapine/Intense Behavioral Weight Intervention	101	37

Primary outcome: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants

Time frame: Baseline, 52 weeks. Least squares mean (Standard Error). Unit: kilograms per meter squared (kg/m^2)

Measure	Olanzapine/Standard Behavioral Weight Intervention n = 102	Olanzapine/Intense Behavioral Weight Intervention n = 101
Value	3.64 (.39)	2.83 (.40)

Olanzapine/Standard Behavioral Weight Intervention vs Olanzapine/Intense Behavioral Weight Intervention: p = 0.150, Mixed Models Analysis

Population analysed: All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olanzapine/Standard Behavioral Weight Intervention	13 of 102 (12.7%)	81 of 102 (79.4%)	Not reported
Olanzapine/Intense Behavioral Weight Intervention	20 of 101 (19.8%)	81 of 101 (80.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27676420Detke HC, DelBello MP, Landry J, Hoffmann VP, Heinloth A, Dittmann RW. A 52-Week Study of Olanzapine with a Randomized Behavioral Weight Counseling Intervention in Adolescents with Schizophrenia or Bipolar I Disorder. J Child Adolesc Psychopharmacol. 2016 Dec;26(10):922-934. doi: 10.1089/cap.2016.0010. Epub 2016 Sep 27.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

14 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Russia, United States, Poland, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00982020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.