Trial Outcomes & Findings for An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia (NCT NCT01129882)
NCT ID: NCT01129882
Last Updated: 2020-01-06
Results Overview
A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
709 participants
Primary outcome timeframe
Baseline to Month 97 (+/- 3 days)
Results posted on
2020-01-06
Participant Flow
Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 31-08-248 (NCT00731549) (completed Study 248 Study Completion visit, Week 52).
Participant milestones
| Measure |
Aripiprazole IM Depot
Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
|
|---|---|
|
Overall Study
STARTED
|
709
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
709
|
|
Overall Study
COMPLETED
|
431
|
|
Overall Study
NOT COMPLETED
|
278
|
Reasons for withdrawal
| Measure |
Aripiprazole IM Depot
Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
|
|---|---|
|
Overall Study
Adverse Event
|
39
|
|
Overall Study
Death
|
6
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Physician Decision
|
27
|
|
Overall Study
Protocol Deviation
|
3
|
|
Overall Study
Withdrawal Criteria Met
|
19
|
|
Overall Study
Trial Termination by Sponsor
|
6
|
|
Overall Study
Withdrawal by Subject
|
160
|
Baseline Characteristics
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole IM Depot
n=709 Participants
Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
709 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Age (years)
|
41.9 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
295 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
414 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
464 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 97 (+/- 3 days)Population: The Safety Sample includes all participants who received at least 1 dose of open-label aripiprazole IM depot.
A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Aripiprazole IM Depot
n=709 Participants
Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
|
|---|---|
|
Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)
|
50 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 91Population: The Efficacy Sample comprises those participants who entered the trial and had at least 1 post-baseline efficacy evaluation.
The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The Last Visit was defined as the last available post-baseline evaluation. A decrease in the CGI-S score indicated disease stability or improvement.
Outcome measures
| Measure |
Aripiprazole IM Depot
n=703 Participants
Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
|
|---|---|
|
Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit
|
-0.14 units on a scale
Standard Deviation 0.69
|
Adverse Events
Aripiprazole IM Depot
Serious events: 62 serious events
Other events: 515 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Aripiprazole IM Depot
n=709 participants at risk
Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Congenital, familial and genetic disorders
Vitello-Intestinal Duct Remnant
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
General disorders
Death
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Pneumonia
|
0.42%
3/709 • Number of events 3 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Influenza
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Urinary Tract Infection
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Infection
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Erysipelas
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Abscess Jaw
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Abdominal Abscess
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Abdominal Infection
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Dengue Fever
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Bacteraemia
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Cellulitis
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Investigations
Hepatic Enzyme Increased
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Metabolism and nutrition disorders
Haemosiderosis
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Musculoskeletal and connective tissue disorders
Still's Disease
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar Tumour
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic Adenoma
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Nervous system disorders
Presyncope
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Nervous system disorders
Thrombotic Cerebral Infarction
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Nervous system disorders
Seizure
|
0.28%
2/709 • Number of events 2 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Nervous system disorders
Loss of Consciousness
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Psychotic Disorder
|
1.3%
9/709 • Number of events 9 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Suicide Attempt
|
0.28%
2/709 • Number of events 2 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Schizophrenia
|
2.0%
14/709 • Number of events 14 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Insomnia
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Aggression
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Delusion
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Acute Stress Disorder
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Impulse-Control Disorder
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Reproductive system and breast disorders
Cystocele
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Social circumstances
Poor Personal Hygiene
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Vascular disorders
Hypertension
|
0.14%
1/709 • Number of events 1 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
Other adverse events
| Measure |
Aripiprazole IM Depot
n=709 participants at risk
Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
37/709 • Number of events 37 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Influenza
|
6.8%
48/709 • Number of events 48 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Nasopharyngitis
|
12.3%
87/709 • Number of events 87 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.6%
54/709 • Number of events 54 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Investigations
Weight Increased
|
11.4%
81/709 • Number of events 81 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
42/709 • Number of events 42 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Nervous system disorders
Headache
|
10.9%
77/709 • Number of events 77 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Anxiety
|
6.2%
44/709 • Number of events 44 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
|
Psychiatric disorders
Insomnia
|
9.9%
70/709 • Number of events 70 • Baseline to Month 97 (+/- 3 days)
The Safety Sample comprised all participants who received at least 1 dose of open-label aripiprazole IM depot.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 1-609-524-6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
- Publication restrictions are in place
Restriction type: OTHER