Trial · NCT00088465

Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

NCT00088465, Phase 3, Completed, Eli Lilly and Company; results first posted 2012-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder. Trials, record NCT00088465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088465

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
NCT number: NCT00088465
Status: Completed
Phases: Phase 3
Enrollment: 931 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Schizophrenic Disorders, Schizoaffective Disorder
Interventions: Intramuscular olanzapine depot
First posted: 2004-07-27
Last updated: 2012-01-11
Results first posted: 2012-01-11

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events (AE)	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.
Primary	Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline	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.
Primary	Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline	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.
Primary	Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline	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.
Primary	Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline	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.
Primary	Change From Baseline in Weight at Month 76 Endpoint	Baseline, up to 76 months	Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
Primary	Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint	Randomization to end of study up to 76 months	PCS weight gain is defined as a ≥7% increase in weight from baseline.
Primary	Number of Participants With Extrapyramidal Symptoms at Any Time	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.
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint	Baseline, up to 76 months	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.
Secondary	Change From Baseline in PANSS Positive Scores at Month 76 Endpoint	Baseline, up to 76 months	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.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events (AE)	Randomization to end of study up to 76 months	All randomized participants who took at least one dose of study drug.	participants	NUMBER
SECONDARY	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint	Baseline, up to 76 months	Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).	units on a scale	MEAN
SECONDARY	Change From Baseline in PANSS Positive Scores at Month 76 Endpoint	Baseline, up to 76 months	Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).	units on a scale	MEAN
SECONDARY	Change From Baseline in PANSS Negative Scores at Month 76 Endpoint	Baseline, up to 76 months	Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).	units on a scale	MEAN
SECONDARY	Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint	Baseline, up to 76 months	Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).	units on a scale	MEAN
SECONDARY	Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint	Baseline, up to 72 months	Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).	units on a scale	MEAN
SECONDARY	Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint	Baseline, up to 76 months	Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).	units on a scale	MEAN
SECONDARY	Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint	Baseline, up to 76 months	Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).	units on a scale	MEAN
SECONDARY	Number of Psychiatric Visits	Randomization to end of study up to 76 months	All randomized participants who took at least one dose of study drug.	visits	NUMBER
SECONDARY	Days of Hospitalization	Randomization to end of study up to 76 months	All randomized participants who took at least one dose of study drug.	days	NUMBER

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group37

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events (AE)	Intramuscular Olanzapine Depot	AE	501		participants
Number of Participants With Adverse Events (AE)	Intramuscular Olanzapine Depot	SAE	170		participants
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint	Intramuscular Olanzapine Depot		0.30	Standard Deviation 16.42	units on a scale
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint	Intramuscular Olanzapine Depot		0.21	Standard Deviation 4.69	units on a scale
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint	Intramuscular Olanzapine Depot		-0.08	Standard Deviation 5.14	units on a scale
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint	Intramuscular Olanzapine Depot		0.19	Standard Deviation 8.51	units on a scale
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint	Intramuscular Olanzapine Depot		-0.17	Standard Error 0.03	units on a scale
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint	Intramuscular Olanzapine Depot		6.75	Standard Deviation 18.55	units on a scale
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint	Intramuscular Olanzapine Depot	Mental component summary	0.94	Standard Deviation 11.05	units on a scale
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint	Intramuscular Olanzapine Depot	Physical component summary	-0.36	Standard Deviation 8.34	units on a scale

1 to 10 of 37Source ClinicalTrials.gov

See all 37 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intramuscular Olanzapine Depot	931
Overall Study	COMPLETED	Intramuscular Olanzapine Depot	370
Overall Study	NOT COMPLETED	Intramuscular Olanzapine Depot	561

Source ClinicalTrials.gov

Adverse events135

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	Intramuscular Olanzapine Depot	74	931	84
other	Weight increased	Investigations	Intramuscular Olanzapine Depot	134	931	136
other	Dizziness	Nervous system disorders	Intramuscular Olanzapine Depot	50	931	57
other	Headache	Nervous system disorders	Intramuscular Olanzapine Depot	67	931	72
other	Somnolence	Nervous system disorders	Intramuscular Olanzapine Depot	85	931	101
other	Anxiety	Psychiatric disorders	Intramuscular Olanzapine Depot	90	931	94
other	Depression	Psychiatric disorders	Intramuscular Olanzapine Depot	48	931	48
other	Insomnia	Psychiatric disorders	Intramuscular Olanzapine Depot	90	931	92
serious	Iron deficiency anaemia	Blood and lymphatic system disorders	Intramuscular Olanzapine Depot	1	931	1
serious	Cardiac failure	Cardiac disorders	Intramuscular Olanzapine Depot	1	931	1

1 to 10 of 135Source ClinicalTrials.gov

See all 135 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intramuscular Olanzapine Depot
Total, other adverse events	Intramuscular Olanzapine Depot	501	931
Total, serious adverse events	Intramuscular Olanzapine Depot	170	931

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20537128	DERIVED	PubMed
20537130	DERIVED	PubMed
22935168	DERIVED	PubMed
24423017	DERIVED	PubMed
24850228	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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