Schizophrenia
Conditions
Keywords
Relapse, Remission, Recovery
Brief summary
The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.
Interventions
1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period.
BEHAVIORALComputerized cognitive and functional skills training
Self-administered cognitive and technology focused skills training, administered at home for 2 hours per week for the first 12 weeks of the 12-month study period.
Sponsors
University of Miami
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults 2. Diagnosis of schizophrenia 3. Current Hospitalization or outpatient relapse 4. Fewer than four previous admissions 5. Willing to accept long-acting injectable treatment and participate in rehabilitation
Exclusion criteria
1. Primary diagnosis other than schizophrenia 2. Prior Long Acting Injectable treatment 3. Current Suicide Risk 4. Hypersensitivity to Aripiprazole 5. Pregnancy 6. Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases) 7. Unable to give personal informed consent 8. History of treatment resistance as evidenced by clozapine treatment 9. Unable to stop treatment with medications that are strong Cytochrome (CYP) 2D6 or CYP 3A4 inhibitors and or strong CYP3A4 inducers (2.3, 7.1) for at 14 days prior to initiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Develop Sustained Remission of Symptoms of Schizophrenia as Measured as Having a Score of 3 or Less on All 6 Critical Items From the Positive and Negative Syndrome Scale (PANSS) | 6 months | PANSS has 6 critical items with each item being scored from 1 to 7 with the higher score indicating more severe symptoms. A score of 3 or less on all six critical items defines the presence of remission. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDante Durand, MD
University of Miami Miller School
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
None listed