NCT00088465

Brief Summary

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to:

  • Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
  • Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
  • Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Trial Health

98
On Track

Trial Health Score

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

Enrollment
931

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_3

Geographic Reach
24 countries

89 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

First Submitted

Initial submission to the registry

July 26, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2004

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2004

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 11, 2012

Completed
Last Updated

January 11, 2012

Status Verified

December 1, 2011

Enrollment Period

6.3 years

First QC Date

July 26, 2004

Results QC Date

October 14, 2011

Last Update Submit

December 9, 2011

Conditions

Schizophrenic DisordersSchizoaffective Disorder

Outcome Measures

Primary Outcomes (8)

  • Number of Participants With Adverse Events (AE)

    The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.

    Randomization to end of study up to 76 months

  • Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline

    Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.

    Randomization to end of study up to 76 months

  • Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline

    High ALT is defined as a baseline value of \<3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of \<5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of \<2 times the ULN to ≥2 times the ULN at any time post baseline.

    Randomization to end of study up to 76 months

  • Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline

    Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.

    Randomization to end of study up to 76 months

  • Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline

    Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides \<150 mg/dL at baseline to ≥200 mg/dL and \<500 mg/dL any time post baseline.

    Randomization to end of study up to 76 months

  • Change From Baseline in Weight at Month 76 Endpoint

    Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.

    Baseline, up to 76 months

  • Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint

    PCS weight gain is defined as a ≥7% increase in weight from baseline.

    Randomization to end of study up to 76 months

  • Number of Participants With Extrapyramidal Symptoms at Any Time

    Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) \>3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.

    Randomization to end of study up to 76 months

Secondary Outcomes (12)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint

    Baseline, up to 76 months

  • Change From Baseline in PANSS Positive Scores at Month 76 Endpoint

    Baseline, up to 76 months

  • Change From Baseline in PANSS Negative Scores at Month 76 Endpoint

    Baseline, up to 76 months

  • Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint

    Baseline, up to 76 months

  • Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint

    Baseline, up to 72 months

  • +7 more secondary outcomes

Study Arms (1)

Intramuscular Olanzapine Depot

EXPERIMENTAL

Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Drug: Intramuscular olanzapine depot

Interventions

Intramuscular olanzapine depotDRUG

45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.

Also known as: LY170053, Zyprexa Adhera
Intramuscular Olanzapine Depot

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have schizophrenia
  • Female patients of childbearing potential must be using a medically accepted means of contraception
  • Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.

You may not qualify if:

  • Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry
  • Female patients must not be pregnant or breast-feeding
  • Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder
  • Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (92)

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Orange, California, 92868, United States

Location

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Pasadena, California, 91107, United States

Location

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San Diego, California, 92123, United States

Location

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Santa Ana, California, 92705, United States

Location

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

Location

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Bradenton, Florida, 34208, United States

Location

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Honolulu, Hawaii, 96826, United States

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Chicago, Illinois, 60640, United States

Location

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Indianapolis, Indiana, 46222, United States

Location

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Lake Charles, Louisiana, 70601, United States

Location

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St Louis, Missouri, 63118, United States

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Las Vegas, Nevada, 89102, United States

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Reno, Nevada, 89512, United States

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Albuquerque, New Mexico, 87131, United States

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Cedarhurst, New York, 11516, United States

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New York, New York, 10035, United States

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Rochester, New York, 14624, United States

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Chagrin Falls, Ohio, 44022, United States

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Chardon, Ohio, 44024, United States

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Houston, Texas, 77007, United States

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Kirkland, Washington, 98033, United States

Location

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Buenos Aires, 1221, Argentina

Location

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Lanús Este, B18241BR, Argentina

Location

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Mendoza, M5500GAC, Argentina

Location

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Herston, Queensland, 4029, Australia

Location

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Glenside, South Australia, 5065, Australia

Location

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Dandenong, Victoria, 3175, Australia

Location

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Vienna, 1010, Austria

Location

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Diest, 3290, Belgium

Location

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Liège, 4000, Belgium

Location

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Aparecida de Goiânia, 74922-810, Brazil

Location

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Rio de Janeiro, 21020-130, Brazil

Location

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Salvador, 40301500, Brazil

Location

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Zagreb, 10000, Croatia

Location

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Prague, 181 03, Czechia

Location

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Bayonne, 64109, France

Location

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Bourg-en-Bresse, 01000, France

Location

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Dijon, 21033, France

Location

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Dole, 39100, France

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Fontaine, 38600, France

Location

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La Roche-sur-Foron, 74800, France

Location

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La Seyne-sur-Mer, 83500, France

Location

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Limoges, 87025, France

Location

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Narbonne, 11108, France

Location

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Paris, 75674, France

Location

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Saint-Cyr-au-Mont-d'Or, 69450, France

Location

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Strasbourg, 67000, France

Location

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Suresnes, 92150, France

Location

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Bad Saarow, D-15526, Germany

Location

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Berlin, 10117, Germany

Location

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Halle, D-06097, Germany

Location

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Hamburg, D-20251, Germany

Location

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Mainz, D-55101, Germany

Location

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München, D-81675, Germany

Location

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Budapest, 1083, Hungary

Location

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Beer Yaacov, 70350, Israel

Location

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Hod HaSharon, 45100, Israel

Location

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Lev Hasharon, 42100, Israel

Location

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Florence, 50134, Italy

Location

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Savigliano, 12038, Italy

Location

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Torino, 10126, Italy

Location

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Guadalajara, 45170, Mexico

Location

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Mexico City, 14420, Mexico

Location

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Monterrey, 64000, Mexico

Location

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Enschede, 7546 TA, Netherlands

Location

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The Hague, 2553 RJ, Netherlands

Location

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Gdynia, 81-361, Poland

Location

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Torun, 87 100, Poland

Location

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Braga, 4710-200, Portugal

Location

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Coimbra, 3031801, Portugal

Location

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Lisbon, 1169053, Portugal

Location

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Porto, 4200-272, Portugal

Location

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Mayagüez, 00680, Puerto Rico

Location

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Ponce, 00716, Puerto Rico

Location

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Rio Piedras, 00926, Puerto Rico

Location

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San Juan, 00918, Puerto Rico

Location

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Bucharest, 73120, Romania

Location

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Craiova, 200738, Romania

Location

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Iași, 700282, Romania

Location

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Moscow, 115522, Russia

Location

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Saint Petersburg, 194044, Russia

Location

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Bratislava, 826 06, Slovakia

Location

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George, 6530, South Africa

Location

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Randburg, 2125, South Africa

Location

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Barcelona, 08500, Spain

Location

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Burgos, 09006, Spain

Location

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Málaga, 29010, Spain

Location

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Seville, 41700, Spain

Location

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Falköping, 52185, Sweden

Location

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Stockholm, 11895, Sweden

Location

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Taipei, 112, Taiwan

Location

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Taoyuan District, 333, Taiwan

Location

Related Publications (5)

  • McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014 Nov;29(6):322-31. doi: 10.1097/YIC.0000000000000038.

    PMID: 24850228DERIVED

  • 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

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2004

First Posted

July 27, 2004

Study Start

August 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 11, 2012

Results First Posted

January 11, 2012

Record last verified: 2011-12

Locations

RO(3)AU(1)BE(2)NL(2)ES(4)TW(2)DE(6)IL(3)HU(1)PL(2)PR(4)IT(3)CZ(1)PT(4)US(21)RU(2)BR(3)ME(3)SL(1)SE(2)AR(3)CR(1)FR(13)ZA(2)