Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
This study has been completed.
Sponsor:
Eli Lilly and Company
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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
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
| 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| 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
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided by Eli Lilly and Company
Publications automatically indexed to this study:
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| 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 |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979
Organization: Eli Lilly and Company
phone: 800-545-5979
No publications provided by Eli Lilly and Company
Publications automatically indexed to this study:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00088465 History of Changes |
| Other Study ID Numbers: | 5995, F1D-MC-HGKB |
| Study First Received: | July 26, 2004 |
| Results First Received: | October 14, 2011 |
| Last Updated: | December 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |