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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00088465




Registration number
NCT00088465
Ethics application status
Date submitted
26/07/2004
Date registered
27/07/2004
Date last updated
11/01/2012

Titles & IDs
Public title
Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Scientific title
An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Secondary ID [1] 0 0
F1D-MC-HGKB
Secondary ID [2] 0 0
5995
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenic Disorders 0 0
Schizoaffective Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Intramuscular olanzapine depot

Experimental: Intramuscular Olanzapine Depot - Intramuscular (IM) olanzapine depot flexible dosing and flexible interval


Treatment: Drugs: Intramuscular olanzapine depot
45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AE)
Timepoint [1] 0 0
Randomization to end of study up to 76 months
Primary outcome [2] 0 0
Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
Timepoint [2] 0 0
Randomization to end of study up to 76 months
Primary outcome [3] 0 0
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
Timepoint [3] 0 0
Randomization to end of study up to 76 months
Primary outcome [4] 0 0
Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
Timepoint [4] 0 0
Randomization to end of study up to 76 months
Primary outcome [5] 0 0
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
Timepoint [5] 0 0
Randomization to end of study up to 76 months
Primary outcome [6] 0 0
Change From Baseline in Weight at Month 76 Endpoint
Timepoint [6] 0 0
Baseline, up to 76 months
Primary outcome [7] 0 0
Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
Timepoint [7] 0 0
Randomization to end of study up to 76 months
Primary outcome [8] 0 0
Number of Participants With Extrapyramidal Symptoms at Any Time
Timepoint [8] 0 0
Randomization to end of study up to 76 months
Secondary outcome [1] 0 0
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
Timepoint [1] 0 0
Baseline, up to 76 months
Secondary outcome [2] 0 0
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
Timepoint [2] 0 0
Baseline, up to 76 months
Secondary outcome [3] 0 0
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
Timepoint [3] 0 0
Baseline, up to 76 months
Secondary outcome [4] 0 0
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
Timepoint [4] 0 0
Baseline, up to 76 months
Secondary outcome [5] 0 0
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
Timepoint [5] 0 0
Baseline, up to 72 months
Secondary outcome [6] 0 0
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint
Timepoint [6] 0 0
Baseline, up to 76 months
Secondary outcome [7] 0 0
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
Timepoint [7] 0 0
Baseline, up to 76 months
Secondary outcome [8] 0 0
Number of Psychiatric Visits
Timepoint [8] 0 0
Randomization to end of study up to 76 months
Secondary outcome [9] 0 0
Days of Hospitalization
Timepoint [9] 0 0
Randomization to end of study up to 76 months
Secondary outcome [10] 0 0
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint
Timepoint [10] 0 0
Baseline, up to 76 months
Secondary outcome [11] 0 0
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
Timepoint [11] 0 0
Randomization to end of study up to 76 months
Secondary outcome [12] 0 0
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
Timepoint [12] 0 0
Randomization to end of study up to 76 months

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
931
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
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. - Herston
Recruitment hospital [2] 0 0
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. - Glenside
Recruitment hospital [3] 0 0
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. - Dandenong
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5065 - Glenside
Recruitment postcode(s) [3] 0 0
3175 - Dandenong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Lanus Este
Country [17] 0 0
Argentina
State/province [17] 0 0
Mendoza
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
Country [19] 0 0
Belgium
State/province [19] 0 0
Diest
Country [20] 0 0
Belgium
State/province [20] 0 0
Liège
Country [21] 0 0
Brazil
State/province [21] 0 0
Aparecida De Goiania
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio De Janeiro
Country [23] 0 0
Brazil
State/province [23] 0 0
Salvador
Country [24] 0 0
Croatia
State/province [24] 0 0
Zagreb
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Prague
Country [26] 0 0
France
State/province [26] 0 0
Bayonne
Country [27] 0 0
France
State/province [27] 0 0
Bourg En Bresse
Country [28] 0 0
France
State/province [28] 0 0
Dijon
Country [29] 0 0
France
State/province [29] 0 0
Dole
Country [30] 0 0
France
State/province [30] 0 0
Fontaine
Country [31] 0 0
France
State/province [31] 0 0
La Roche Sur Foron
Country [32] 0 0
France
State/province [32] 0 0
La Seyne Sur Mer
Country [33] 0 0
France
State/province [33] 0 0
Limoges
Country [34] 0 0
France
State/province [34] 0 0
Narbonne
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Saint Cyr Au Mont D'Or
Country [37] 0 0
France
State/province [37] 0 0
Strasbourg
Country [38] 0 0
France
State/province [38] 0 0
Suresnes
Country [39] 0 0
Germany
State/province [39] 0 0
Bad Saarow
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Halle
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Mainz
Country [44] 0 0
Germany
State/province [44] 0 0
München
Country [45] 0 0
Hungary
State/province [45] 0 0
Budapest
Country [46] 0 0
Israel
State/province [46] 0 0
Beer Yaacov
Country [47] 0 0
Israel
State/province [47] 0 0
Hod-Hasharon
Country [48] 0 0
Israel
State/province [48] 0 0
Lev Hasharon
Country [49] 0 0
Italy
State/province [49] 0 0
Firenze
Country [50] 0 0
Italy
State/province [50] 0 0
Savigliano
Country [51] 0 0
Italy
State/province [51] 0 0
Torino
Country [52] 0 0
Mexico
State/province [52] 0 0
Guadalajara
Country [53] 0 0
Mexico
State/province [53] 0 0
Mexico City
Country [54] 0 0
Mexico
State/province [54] 0 0
Monterrey
Country [55] 0 0
Netherlands
State/province [55] 0 0
Den Haag
Country [56] 0 0
Netherlands
State/province [56] 0 0
Enschede
Country [57] 0 0
Poland
State/province [57] 0 0
Gdynia
Country [58] 0 0
Poland
State/province [58] 0 0
Torun
Country [59] 0 0
Portugal
State/province [59] 0 0
Braga
Country [60] 0 0
Portugal
State/province [60] 0 0
Coimbra
Country [61] 0 0
Portugal
State/province [61] 0 0
Lisbon
Country [62] 0 0
Portugal
State/province [62] 0 0
Porto
Country [63] 0 0
Puerto Rico
State/province [63] 0 0
Mayaguez
Country [64] 0 0
Puerto Rico
State/province [64] 0 0
Ponce
Country [65] 0 0
Puerto Rico
State/province [65] 0 0
Rio Piedras
Country [66] 0 0
Puerto Rico
State/province [66] 0 0
San Juan
Country [67] 0 0
Romania
State/province [67] 0 0
Bucharest
Country [68] 0 0
Romania
State/province [68] 0 0
Craiova
Country [69] 0 0
Romania
State/province [69] 0 0
Iasi
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Saint Petersburg
Country [72] 0 0
Slovakia
State/province [72] 0 0
Bratislava
Country [73] 0 0
South Africa
State/province [73] 0 0
George
Country [74] 0 0
South Africa
State/province [74] 0 0
Randburg
Country [75] 0 0
Spain
State/province [75] 0 0
Barcelona
Country [76] 0 0
Spain
State/province [76] 0 0
Burgos
Country [77] 0 0
Spain
State/province [77] 0 0
Málaga
Country [78] 0 0
Spain
State/province [78] 0 0
Sevilla
Country [79] 0 0
Sweden
State/province [79] 0 0
Falköping
Country [80] 0 0
Sweden
State/province [80] 0 0
Stockholm
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei
Country [82] 0 0
Taiwan
State/province [82] 0 0
Tao-Yuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00088465
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00088465