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

Phase 3

Completed

Conditions: Schizophrenic Disorders
Schizoaffective Disorder

Interventions: Drug: Intramuscular olanzapine depot

Registration Number: NCT00088465

Lead Sponsor: Eli Lilly and Company

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 931

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intramuscular Olanzapine Depot	Intramuscular olanzapine depot	Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint	Baseline, up to 76 months	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 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.
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint	Baseline, up to 76 months	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	Baseline, up to 72 months	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	Baseline, up to 76 months	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	Baseline, up to 76 months	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	Randomization to end of study up to 76 months	Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.
Days of Hospitalization	Randomization to end of study up to 76 months	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	Baseline, up to 76 months	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	Randomization to end of study up to 76 months	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	Randomization to end of study up to 76 months	Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) (\[ng/mL\]/\[mg/day\]).

Trial Locations

Locations (1): 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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Tao-Yuan, Taiwan