NCT00320489|CompletedPhase 3Results

Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

6390F1D-MC-HGLQ

Study Type

interventional

Target

524

Locations

12 countries

Sites

Timeline

RegisteredMay 2006

StartedApr 2006

CompletionSep 2009

Brief Summary

To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.

Trial Health

On Track

Trial Health Score

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

Enrollment

524

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline

Completed

Started Apr 2006

Longer than P75 for phase_3 schizophrenia

Geographic Reach

12 countries

49 active sites

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

3.4 years study duration

Study Start

First participant enrolled

April 1, 2006

Completed

27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 22, 2010

Completed

Last Updated

January 23, 2012

Status Verified

January 1, 2012

Enrollment Period

3.4 years

First QC Date

April 28, 2006

Results QC Date

September 29, 2010

Last Update Submit

January 19, 2012

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)
Baseline up to 104 weeks

Secondary Outcomes (25)

Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks
Baseline, 104 weeks
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores
Baseline, 104 weeks
Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks
Baseline, 104 weeks
Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks
Baseline, 104 weeks
Resource Utilization: Number of Outpatient Physician Visits During the Study
Baseline through 104 weeks
+20 more secondary outcomes

Study Arms (2)

Olanzapine Pamoate Depot

EXPERIMENTAL

Olanzapine pamoate depot

Drug: olanzapine pamoate depot

Olanzapine

ACTIVE COMPARATOR

Oral olanzapine

Drug: olanzapine

Interventions

olanzapineDRUG

10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.

Also known as: LY170053, Zyprexa

Olanzapine

olanzapine pamoate depotDRUG

405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.

Olanzapine Pamoate Depot

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinical diagnosis of schizophrenia
Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
Disease symptoms must meet a certain range as assessed by the clinician.
Patient has experienced at least two episodes of clinical worsening of their condition. This could mean admission to a hospital or an emergency room visit. This could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
The patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.

You may not qualify if:

Patients who are actively suicidal.
Patients who are pregnant or nursing.
Patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
Patients with Parkinson's disease, psychosis related to dementia or other related disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (49)

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.

Escondido, California, 92025, United States

Location

National City, California, 91950, United States

Location

Orange, California, 92868, United States

Location

San Diego, California, 92123, United States

Location

Washington D.C., District of Columbia, 20016, United States

Location

Honolulu, Hawaii, 96826, United States

Location

Chicago, Illinois, 60640, United States

Location

Cedarhurst, New York, 11516, United States

Location

Staten Island, New York, 10305, United States

Location

Canton, Ohio, 44708, United States

Location

Allentown, Pennsylvania, 18104, United States

Location

Philadelphia, Pennsylvania, 19139, United States

Location

West Chester, Pennsylvania, 19380, United States

Location

Banfield, B1828CKR, Argentina

Location

Buenos Aires, 1118, Argentina

Location

Mendoza, M5500GAC, Argentina

Location

Pelotas, 96030-000, Brazil

Location

Rio de Janeiro, 21020-130, Brazil

Location

São Paulo, 04044-000, Brazil

Location

Calgary, Alberta, T2N 2T9, Canada

Location

Winnipeg, Manitoba, R3E 3N4, Canada

Location

Burlington, Ontario, L7N 3V2, Canada

Location

Chatham, Ontario, N7L 1B7, Canada

Location

Greater Sudbury, Ontario, P3E 1X3, Canada

Location

Montreal, Quebec, H3A 1A1, Canada

Location

Dijon, 21033, France

Location

Dole, 39100, France

Location

La Seyne-sur-Mer, 83500, France

Location

Limoges, 87025, France

Location

Strasbourg, 67000, France

Location

Toulon, 83506, France

Location

Chaïdári, 12461, Greece

Location

Haidari, Athens, 12462, Greece

Location

Thessaloniki, 54630, Greece

Location

Tripoli, 22100, Greece

Location

Lisbon, 1169053, Portugal

Location

Cabo Rojo, 00623, Puerto Rico

Location

Caguas, 00725, Puerto Rico

Location

Mayagüez, 00680, Puerto Rico

Location

Rio Piedras, 00926, Puerto Rico

Location

Bucharest, 73120, Romania

Location

Iași, 700282, Romania

Location

Târgu Mureş, 540139, Romania

Location

Bratislava, 826 06, Slovakia

Location

Alzira, 46600, Spain

Location

Barcelona, 08003, Spain

Location

Hua-Lian County, 981, Taiwan

Location

Taipei, 114, Taiwan

Location

Taoyuan, 330, Taiwan

Location

Related Publications (4)

Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.
PMID: 24423017DERIVED
Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.
PMID: 22935168DERIVED
McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.
PMID: 20537130DERIVED
Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.
PMID: 20537128DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Results for Outcome Measures 17 and 18 were corrected as a result of an identified programming error.

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

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

Publication Agreements

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

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Start

April 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 23, 2012

Results First Posted

October 22, 2010

Record last verified: 2012-01

Locations

BR(3)PT(1)AR(3)RO(3)CA(6)PR(4)SL(1)TW(3)GR(4)FR(6)US(13)ES(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (25)

Study Arms (2)

Olanzapine Pamoate Depot

Olanzapine

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (49)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations