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Recruitment issues
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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
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The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole and Computerized Cognitive and Functional Skills Training Group | Experimental | Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole Lauroxil | Drug | 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dante Durand, MD | University of Miami Miller School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole and Computerized Cognitive and Functional Skills Training Group | Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation. Aripiprazole Lauroxil: 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. Computerized 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole and Computerized Cognitive and Functional Skills Training Group | Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation. Aripiprazole Lauroxil: 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. Computerized 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Number | Percentage of participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole and Computerized Cognitive and Functional Skills Training Group | Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation. Aripiprazole Lauroxil: 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. Computerized 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dante Durand, Associate Professor of Psychiatry | University of Miami | 305-355-8237 | ddurand@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2024 | Jan 7, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000603935 | aripiprazole lauroxil |
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| Computerized cognitive and functional skills training | Behavioral | 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. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D013568 | Pathological Conditions, Signs and Symptoms |