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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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This study compares aripiprazole once-monthly injection to standard of care oral antipsychotic medication in non-adherent outpatients with schizophrenia to see which treatment helps people take their medicine more regularly and have more positive outcomes.
It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole once-monthly will be more likely to respond and have lower symptom severity over 3 months of treatment than those receiving standard of care oral antipsychotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole Once-Monthly | Experimental | Switch to 400 mg aripiprazole once-monthly injection |
|
| Standard of Care | Active Comparator | Continue current SOC oral antipsychotic medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole Once-Monthly | Drug |
| ||
| Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: PANSS (Positive and Negative Syndrome Scale) total score improvement - response | PANSS total score - operationalized as a binary response, defined as at least a 20% improvement in PANSS totals core, from the three monthly visits. | from date of randomization up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: PANSS total score overall - symptom severity | PANSS total score - continuous, from the three monthly visits | from date of randomization up to 3 months |
| Quality of Life | Schizophrenia Quality of Life Scale (SQLS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Bannister | Contact | 214-648-4603 | elizabeth.bannister@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matt Byerly, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Drug |
Oral antipsychotic medication |
|
| from date of randomization up to 3 months |
| Cognition | Brief Assessment of Cognition in Schizophrenia (BACS) | from date of randomizatino up to 3 months |
| Substance Use | Alcohol Use Scale (AUS) and Drug Use Scale (DUS) | from date of randomization up to 3 months |
| Safety assessed by Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS) | Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS) | from date of randomization up to 3 months |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014150 | Antipsychotic Agents |
| D018967 | Risperidone |
| D000069056 | Lurasidone Hydrochloride |
| D000069348 | Quetiapine Fumarate |
| D000077152 | Olanzapine |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
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