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

Primary Purpose

Schizophrenic Disorders, Schizoaffective Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Intramuscular olanzapine depot

About this trial

This is an interventional treatment trial for Schizophrenic Disorders

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intramuscular Olanzapine Depot

Arm Description

Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Change From Baseline in Weight at Month 76 Endpoint

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

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

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.

Secondary Outcome Measures

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.

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.

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.

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.

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).

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.

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.

Number of Psychiatric Visits

Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.

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).

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.

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.

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]).

Full Information

NCT ID

NCT00088465

First Posted

July 26, 2004

Last Updated

December 9, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00088465

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenic Disorders, Schizoaffective Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

931 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intramuscular Olanzapine Depot

Arm Type

Experimental

Arm Description

Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Intervention Type

Drug

Intervention Name(s)

Intramuscular olanzapine depot

Other Intervention Name(s)

LY170053, Zyprexa Adhera

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AE)

Description

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

Time Frame

Randomization to end of study up to 76 months

Title

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

Description

Time Frame

Randomization to end of study up to 76 months

Title

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

Description

Time Frame

Randomization to end of study up to 76 months

Title

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

Description

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

Time Frame

Randomization to end of study up to 76 months

Title

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

Description

Time Frame

Randomization to end of study up to 76 months

Title

Change From Baseline in Weight at Month 76 Endpoint

Description

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

Time Frame

Baseline, up to 76 months

Title

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

Description

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

Time Frame

Randomization to end of study up to 76 months

Title

Number of Participants With Extrapyramidal Symptoms at Any Time

Description

Time Frame

Randomization to end of study up to 76 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, up to 76 months

Title

Change From Baseline in PANSS Positive Scores at Month 76 Endpoint

Description

Time Frame

Baseline, up to 76 months

Title

Change From Baseline in PANSS Negative Scores at Month 76 Endpoint

Description

Time Frame

Baseline, up to 76 months

Title

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

Description

Time Frame

Baseline, up to 76 months

Title

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

Description

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).

Time Frame

Baseline, up to 72 months

Title

Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint

Description

Time Frame

Baseline, up to 76 months

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint

Description

Time Frame

Baseline, up to 76 months

Title

Number of Psychiatric Visits

Description

Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.

Time Frame

Randomization to end of study up to 76 months

Title

Days of Hospitalization

Description

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).

Time Frame

Randomization to end of study up to 76 months

Title

Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint

Description

Time Frame

Baseline, up to 76 months

Title

Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint

Description

Time Frame

Randomization to end of study up to 76 months

Title

Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year

Description

Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).

Time Frame

Randomization to end of study up to 76 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

City

Pasadena

State/Province

California

ZIP/Postal Code

91107

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96826

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46222

Country

United States

Facility Name

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63118

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

City

Reno

State/Province

Nevada

ZIP/Postal Code

89512

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10035

Country

United States

Facility Name

City

Rochester

State/Province

New York

ZIP/Postal Code

14624

Country

United States

Facility Name

City

Chagrin Falls

State/Province

Ohio

ZIP/Postal Code

44022

Country

United States

Facility Name

City

Chardon

State/Province

Ohio

ZIP/Postal Code

44024

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77007

Country

United States

Facility Name

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

1221

Country

Argentina

Facility Name

City

Lanus Este

ZIP/Postal Code

B18241BR

Country

Argentina

Facility Name

City

Mendoza

ZIP/Postal Code

M5500GAC

Country

Argentina

Facility Name

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

City

Glenside

State/Province

South Australia

ZIP/Postal Code

5065

Country

Australia

Facility Name

City

Dandenong

State/Province

Victoria

ZIP/Postal Code

3175

Country

Australia

Facility Name

City

Wien

ZIP/Postal Code

1010

Country

Austria

Facility Name

City

Diest

ZIP/Postal Code

3290

Country

Belgium

Facility Name

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Aparecida De Goiania

ZIP/Postal Code

74922-810

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

21020-130

Country

Brazil

Facility Name

City

Salvador

ZIP/Postal Code

40301500

Country

Brazil

Facility Name

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

City

Prague

ZIP/Postal Code

181 03

Country

Czech Republic

Facility Name

City

Bayonne

ZIP/Postal Code

64109

Country

France

Facility Name

City

Bourg En Bresse

ZIP/Postal Code

01000

Country

France

Facility Name

City

Dijon

ZIP/Postal Code

21033

Country

France

Facility Name

City

Dole

ZIP/Postal Code

39100

Country

France

Facility Name

City

Fontaine

ZIP/Postal Code

38600

Country

France

Facility Name

City

La Roche Sur Foron

ZIP/Postal Code

74800

Country

France

Facility Name

City

La Seyne Sur Mer

ZIP/Postal Code

83500

Country

France

Facility Name

City

Limoges

ZIP/Postal Code

87025

Country

France

Facility Name

City

Narbonne

ZIP/Postal Code

11108

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75674

Country

France

Facility Name

City

Saint Cyr Au Mont D'Or

ZIP/Postal Code

69450

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

City

Bad Saarow

ZIP/Postal Code

D-15526

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

City

Halle

ZIP/Postal Code

D-06097

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

D-20251

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

D-55101

Country

Germany

Facility Name

City

München

ZIP/Postal Code

D-81675

Country

Germany

Facility Name

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

City

Beer Yaacov

ZIP/Postal Code

70350

Country

Israel

Facility Name

City

Hod-Hasharon

ZIP/Postal Code

45100

Country

Israel

Facility Name

City

Lev Hasharon

ZIP/Postal Code

42100

Country

Israel

Facility Name

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

City

Savigliano

ZIP/Postal Code

12038

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

City

Guadalajara

ZIP/Postal Code

45170

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

14420

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64000

Country

Mexico

Facility Name

City

Den Haag

ZIP/Postal Code

2553 RJ

Country

Netherlands

Facility Name

City

Enschede

ZIP/Postal Code

7546 TA

Country

Netherlands

Facility Name

City

Gdynia

ZIP/Postal Code

81-361

Country

Poland

Facility Name

City

Torun

ZIP/Postal Code

87 100

Country

Poland

Facility Name

City

Braga

ZIP/Postal Code

4710-200

Country

Portugal

Facility Name

City

Coimbra

ZIP/Postal Code

3031801

Country

Portugal

Facility Name

City

Lisbon

ZIP/Postal Code

1169053

Country

Portugal

Facility Name

City

Porto

ZIP/Postal Code

4200-272

Country

Portugal

Facility Name

City

Mayaguez

ZIP/Postal Code

00680

Country

Puerto Rico

Facility Name

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

City

Rio Piedras

ZIP/Postal Code

00926

Country

Puerto Rico

Facility Name

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Bucharest

ZIP/Postal Code

73120

Country

Romania

Facility Name

City

Craiova

ZIP/Postal Code

200738

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700282

Country

Romania

Facility Name

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

City

George

ZIP/Postal Code

6530

Country

South Africa

Facility Name

City

Randburg

ZIP/Postal Code

2125

Country

South Africa

Facility Name

City

Barcelona

ZIP/Postal Code

08500

Country

Spain

Facility Name

City

Burgos

ZIP/Postal Code

09006

Country

Spain

Facility Name

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41700

Country

Spain

Facility Name

City

Falköping

ZIP/Postal Code

52185

Country

Sweden

Facility Name

City

Stockholm

ZIP/Postal Code

11895

Country

Sweden

Facility Name

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

City

Tao-Yuan

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24850228

Citation

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.

Results Reference

derived

PubMed Identifier

24423017

Citation

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.

Results Reference

derived

PubMed Identifier

22935168

Citation

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.

Results Reference

derived

PubMed Identifier

20537130

Citation

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.

Results Reference

derived

PubMed Identifier

20537128

Citation

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.

Results Reference

derived

Learn more about this trial

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

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