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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088465
First received: July 26, 2004
Last updated: December 9, 2011
Last verified: December 2011
Results First Received: October 14, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenic Disorders
Schizoaffective Disorder
Intervention: Drug: Intramuscular olanzapine depot

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Participant Flow:   Overall Study
    Intramuscular Olanzapine Depot  
STARTED     931  
COMPLETED     370  
NOT COMPLETED     561  
Withdrawal by Subject                 290  
Adverse Event                 77  
Lost to Follow-up                 57  
Physician Decision                 45  
Sponsor Decision                 37  
Lack of Efficacy                 27  
Protocol Violation                 17  
Death                 11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Baseline Measures
    Intramuscular Olanzapine Depot  
Number of Participants  
[units: participants]
  931  
Age  
[units: years]
Mean ± Standard Deviation
  39.32  ± 11.67  
Gender  
[units: participants]
 
Female     310  
Male     621  
Race/Ethnicity, Customized  
[units: participants]
 
African     102  
Caucasian     629  
East Asian     39  
Hispanic     140  
Native American     2  
West Asian     19  
Region of Enrollment  
[units: participants]
 
United States     177  
Portugal     18  
Taiwan     30  
Slovakia     13  
Spain     24  
Russian Federation     114  
Israel     29  
Italy     6  
France     55  
Puerto Rico     27  
Australia     11  
South Africa     28  
Netherlands     8  
Austria     10  
Czech Republic     3  
Hungary     13  
Mexico     63  
Argentina     73  
Poland     33  
Brazil     89  
Belgium     13  
Croatia     16  
Romania     34  
Germany     32  
Sweden     9  
Greece     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AE)   [ Time Frame: Randomization to end of study up to 76 months ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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 ]

5.  Primary:   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 ]

6.  Primary:   Change From Baseline in Weight at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

7.  Primary:   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 ]

8.  Primary:   Number of Participants With Extrapyramidal Symptoms at Any Time   [ Time Frame: Randomization to end of study up to 76 months ]

9.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

10.  Secondary:   Change From Baseline in PANSS Positive Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

11.  Secondary:   Change From Baseline in PANSS Negative Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

12.  Secondary:   Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

13.  Secondary:   Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint   [ Time Frame: Baseline, up to 72 months ]

14.  Secondary:   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 ]

15.  Secondary:   Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

16.  Secondary:   Number of Psychiatric Visits   [ Time Frame: Randomization to end of study up to 76 months ]

17.  Secondary:   Days of Hospitalization   [ Time Frame: Randomization to end of study up to 76 months ]

18.  Secondary:   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 ]

19.  Secondary:   Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint   [ Time Frame: Randomization to end of study up to 76 months ]

20.  Secondary:   Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year   [ Time Frame: Randomization to end of study up to 76 months ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Serious Adverse Events
    Intramuscular Olanzapine Depot  
Total, serious adverse events    
# participants affected / at risk     170/931 (18.26%)  
Blood and lymphatic system disorders    
Iron deficiency anaemia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Cardiac disorders    
Cardiac failure † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Cardiac failure acute † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Cardiomyopathy alcoholic † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Hypertrophic cardiomyopathy † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Myocardial infarction † 1  
# participants affected / at risk     3/931 (0.32%)  
# events     3  
Myocardial ischaemia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Ventricular tachycardia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Gastrointestinal disorders    
Abdominal discomfort † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Abdominal pain † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Abdominal pain upper † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Diarrhoea † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Dry mouth † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Inguinal hernia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Intestinal ischaemia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Intestinal perforation † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Subileus † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Toothache † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
General disorders    
Asthenia † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Fatigue † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Malaise † 1  
# participants affected / at risk     3/931 (0.32%)  
# events     3  
Hepatobiliary disorders    
Hepatotoxicity † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Infections and infestations    
Abscess † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Abscess limb † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Appendicitis † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Breast cellulitis † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Cellulitis † 1  
# participants affected / at risk     3/931 (0.32%)  
# events     3  
Ear infection † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Gastroenteritis † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Leptospirosis † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Lobar pneumonia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Pneumonia † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Pyelonephritis acute † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Septic shock † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Urinary tract infection † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Injury, poisoning and procedural complications    
Brain contusion † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Drug exposure during pregnancy † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Fall † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Joint dislocation † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Lower limb fracture † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Overdose † 1  
# participants affected / at risk     3/931 (0.32%)  
# events     3  
Post procedural complication † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     4  
Rib fracture † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Road traffic accident † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Skull fractured base † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Subdural haematoma † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Tendon rupture † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Tibia fracture † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Traumatic brain injury † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Traumatic lung injury † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Investigations    
Blood glucose increased † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Blood potassium decreased † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Blood pressure decreased † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Laboratory test abnormal † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Metabolism and nutrition disorders    
Diabetes mellitus † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Diabetic ketoacidosis † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Electrolyte imbalance † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Hypokalaemia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Polydipsia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Musculoskeletal and connective tissue disorders    
Intervertebral disc protrusion † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Muscle spasms † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Osteoarthritis † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Bladder neoplasm † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Breast cancer † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Metastases to bone † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Metastatic renal cell carcinoma † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Neoplasm † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Non-small cell lung cancer † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Renal cell carcinoma † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Small cell lung cancer stage unspecified † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Nervous system disorders    
Cauda equina syndrome † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Cerebral haematoma † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Cerebrovascular accident † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Cervicobrachial syndrome † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Coma † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Dizziness † 1  
# participants affected / at risk     3/931 (0.32%)  
# events     3  
Dysarthria † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Headache † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Loss of consciousness † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Parkinsonism † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Sedation † 1  
# participants affected / at risk     12/931 (1.29%)  
# events     13  
Somnolence † 1  
# participants affected / at risk     5/931 (0.54%)  
# events     5  
Subarachnoid haemorrhage † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Tremor † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Psychiatric disorders    
Abnormal behaviour † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Acute stress disorder † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Aggression † 1  
# participants affected / at risk     4/931 (0.43%)  
# events     5  
Agitation † 1  
# participants affected / at risk     6/931 (0.64%)  
# events     7  
Alcohol abuse † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Anxiety † 1  
# participants affected / at risk     5/931 (0.54%)  
# events     6  
Completed suicide † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Confusional state † 1  
# participants affected / at risk     4/931 (0.43%)  
# events     5  
Delirium † 1  
# participants affected / at risk     4/931 (0.43%)  
# events     4  
Delusion † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Depression † 1  
# participants affected / at risk     5/931 (0.54%)  
# events     5  
Disorientation † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Emotional disorder † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Hallucination † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Hallucination, auditory † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     2  
Impulsive behaviour † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Mental status changes † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Paranoia † 1  
# participants affected / at risk     5/931 (0.54%)  
# events     5  
Psychotic disorder † 1  
# participants affected / at risk     20/931 (2.15%)  
# events     21  
Restlessness † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Schizophrenia † 1  
# participants affected / at risk     35/931 (3.76%)  
# events     38  
Schizophrenia, paranoid type † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Suicidal behaviour † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Suicidal ideation † 1  
# participants affected / at risk     8/931 (0.86%)  
# events     9  
Suicide attempt † 1  
# participants affected / at risk     4/931 (0.43%)  
# events     4  
Vomiting psychogenic † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Renal and urinary disorders    
Urinary incontinence † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Urinary retention † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Reproductive system and breast disorders    
Menorrhagia † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Respiratory, thoracic and mediastinal disorders    
Asthma † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Chronic obstructive pulmonary disease † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     2  
Dyspnoea † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Haemothorax † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Pneumonia aspiration † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Respiratory failure † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Skin and subcutaneous tissue disorders    
Acne † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Dermatitis † 1  
# participants affected / at risk     2/931 (0.21%)  
# events     3  
Social circumstances    
Social stay hospitalisation † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Surgical and medical procedures    
Plastic surgery † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Vascular disorders    
Hypertension † 1  
# participants affected / at risk     3/931 (0.32%)  
# events     4  
Peripheral arterial occlusive disease † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Thrombophlebitis † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Venous thrombosis limb † 1  
# participants affected / at risk     1/931 (0.11%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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