Schizophrenic DisordersPhase 3NCT00088465
Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
A Phase 3 study testing Intramuscular olanzapine depot in people with Schizophrenic Disorders and Schizoaffective Disorder, run by Eli Lilly and Company at 92 sites in 25 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Schizophrenic Disorders, Schizoaffective Disorder
- What is being tested?
- Intramuscular olanzapine depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 931 participants
- Where
- 92 sitesin 25 countries
- Study dates
- Aug 2004to Dec 2010
- Phase
- Phase 3
- 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 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
92 sites in 25 countries.
92 sites in 25 countries
United States21 sites
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Albuquerque, New Mexico, 87131
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Bradenton, Florida, 34208
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Cedarhurst, New York, 11516
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Chagrin Falls, Ohio, 44022
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Chardon, Ohio, 44024
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Chicago, Illinois, 60640
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Honolulu, Hawaii, 96826
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Houston, Texas, 77007
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Indianapolis, Indiana, 46222
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Kirkland, Washington, 98033
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Lake Charles, Louisiana, 70601
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Las Vegas, Nevada, 89102
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New York, New York, 10035
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Orange, California, 92868
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Pasadena, California, 91107
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Reno, Nevada, 89512
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Rochester, New York, 14624
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San Diego, California, 92123
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Santa Ana, California, 92705
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St Louis, Missouri, 63118
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Washington D.C., District of Columbia, 20016
France13 sites
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Bayonne, 64109
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Bourg-en-Bresse, 01000
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Dijon, 21033
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Dole, 39100
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Fontaine, 38600
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La Roche-sur-Foron, 74800
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La Seyne-sur-Mer, 83500
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Limoges, 87025
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Narbonne, 11108
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Paris, 75674
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Saint-Cyr-au-Mont-d'Or, 69450
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Strasbourg, 67000
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Suresnes, 92150
Germany6 sites
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Bad Saarow, D-15526
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Berlin, 10117
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Halle, D-06097
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Hamburg, D-20251
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Mainz, D-55101
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München, D-81675
Portugal4 sites
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Braga, 4710-200
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Coimbra, 3031801
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Lisbon, 1169053
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Porto, 4200-272
Puerto Rico4 sites
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Mayagüez, 00680
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Ponce, 00716
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Rio Piedras, 00926
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San Juan, 00918
Spain4 sites
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Barcelona, 08500
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Burgos, 09006
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Málaga, 29010
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Seville, 41700
Argentina3 sites
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Buenos Aires, 1221
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Lanús Este, B18241BR
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Mendoza, M5500GAC
Australia3 sites
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Dandenong, Victoria, 3175
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Glenside, South Australia, 5065
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Herston, Queensland, 4029
Brazil3 sites
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Aparecida de Goiânia, 74922-810
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Rio de Janeiro, 21020-130
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Salvador, 40301500
Israel3 sites
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Beer Yaacov, 70350
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Hod HaSharon, 45100
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Lev Hasharon, 42100
Italy3 sites
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Florence, 50134
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Savigliano, 12038
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Torino, 10126
Mexico3 sites
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Guadalajara, 45170
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Mexico City, 14420
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Monterrey, 64000
Romania3 sites
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Bucharest, 73120
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Craiova, 200738
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Iași, 700282
Belgium2 sites
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Diest, 3290
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Liège, 4000
Netherlands2 sites
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Enschede, 7546 TA
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The Hague, 2553 RJ
Poland2 sites
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Gdynia, 81-361
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Torun, 87 100
Russia2 sites
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Moscow, 115522
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Saint Petersburg, 194044
South Africa2 sites
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George, 6530
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Randburg, 2125
Sweden2 sites
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Falköping, 52185
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Stockholm, 11895
Taiwan2 sites
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Taipei, 112
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Taoyuan, 333
Austria1 site
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Vienna, 1010
Croatia1 site
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Zagreb, 10000
Czechia1 site
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Prague, 181 03
Hungary1 site
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Budapest, 1083
Slovakia1 site
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Bratislava, 826 06
About this study
Official title: An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
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
- Conditions
- Schizophrenic Disorders, Schizoaffective Disorder
- Being tested
- Intramuscular olanzapine depot
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular olanzapine depotDrug
Also called LY170053, Zyprexa Adhera
45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Olanzapine Depot | Experimental | Intramuscular (IM) olanzapine depot flexible dosing and flexible interval Receives: Drug: Intramuscular olanzapine depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.
Measured: Baseline, up to 76 months
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.
Measured: Baseline, up to 76 months
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.
Measured: Baseline, up to 76 months
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.
Measured: Baseline, up to 76 months
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Baseline, up to 72 months
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint
Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.
Measured: Baseline, up to 76 months
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.
Measured: Baseline, up to 76 months
Number of Psychiatric Visits
Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.
Measured: Randomization to end of study up to 76 months
Days of Hospitalization
This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).
Measured: Randomization to end of study up to 76 months
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint
The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.
Measured: Baseline, up to 76 months
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.
Measured: Randomization to end of study up to 76 months
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).
Measured: Randomization to end of study up to 76 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2004 (estimated)
- Study startAug 2004
- Primary completionDec 2010
- Study completionDec 2010
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 (5)Papers the sponsor has linked to this study.
- Other trials for Schizophrenic DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 931 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088465
- Sponsor's protocol ID
- 5995
- Other IDs
- F1D-MC-HGKB
- Status last verified
- Dec 2011
- First submitted
- 26 Jul 2004
- Last updated
- 11 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 24850228Atkins 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.
PubMed 24423017Peuskens 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.
PubMed 22935168McDonnell 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.
PubMed 20537130Detke 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.
PubMed 20537128
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00088465
- Acronym / sponsor ID
- 5995
- Conditions
- Schizophrenic Disorders, Schizoaffective Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 931 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jul 2004 (estimated)
- Results
- Posted 11 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Olanzapine Depot | Experimental | Drug: Intramuscular olanzapine depotIntramuscular (IM) olanzapine depot flexible dosing and flexible interval |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Intramuscular olanzapine depotAlso: LY170053, Zyprexa Adhera45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval. | Drug | Intramuscular Olanzapine Depot |
Primary outcome
Number of Participants With Adverse Events (AE)
Time frame: Randomization to end of study up to 76 months
The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.
Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
Time frame: Randomization to end of study up to 76 months
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.
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
Time frame: Randomization to end of study up to 76 months
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.
Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
Time frame: Randomization to end of study up to 76 months
Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
Time frame: Randomization to end of study up to 76 months
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.
Change From Baseline in Weight at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
Time frame: Randomization to end of study up to 76 months
PCS weight gain is defined as a ≥7% increase in weight from baseline.
Number of Participants With Extrapyramidal Symptoms at Any Time
Time frame: Randomization to end of study up to 76 months
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.
12 secondary outcomes
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
Time frame: Baseline, up to 72 months
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Number of Psychiatric Visits
Time frame: Randomization to end of study up to 76 months
Days of Hospitalization
Time frame: Randomization to end of study up to 76 months
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint
Time frame: Baseline, up to 76 months
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
Time frame: Randomization to end of study up to 76 months
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
Time frame: Randomization to end of study up to 76 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24850228McDonnell 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.
- Derived from this study: PubMed 24423017Atkins 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.
- Derived from this study: PubMed 22935168Peuskens 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.
- Derived from this study: PubMed 20537130McDonnell 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.
- Derived from this study: PubMed 20537128Detke 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.
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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
92 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intramuscular olanzapine depot in people with Schizophrenic Disorders and Schizoaffective Disorder, run by Eli Lilly and Company at 92 sites in 25 countries.
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 3 inclusion and 4 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, France, Germany, Portugal, Puerto Rico and 20 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Jan 2012). 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?
Number of Participants With Adverse Events (AE) (time frame: Randomization to end of study up to 76 months). The study lists 8 primary outcomes in all. 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 NCT00088465, which also lists 5 linked publications.
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 11 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.