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We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.
To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Active Comparator | To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (2mg wk1, 5mg wk2, 10mg wk3, 5-30 mg wk4-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need (5-30mg). |
|
| Fluoxetine | Active Comparator | To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (5mg wk1, 10mg wk2, 20mg wk3, 10-60mg wk3-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need(10-60mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | see arm description |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | Time to either all-cause-discontinuation or need to add another psychotropic agent | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prodromal Symptoms (SOPS) Total Scores | Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse) | 24 weeks |
| Number of Patients With Specific Adverse Effects | Number of patients with any adverse effects based on spontaneous report |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph U Correll, MD | North Shore LIJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
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outpatient clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Intervention arm |
| FG001 | Fluoxetine | Active control arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Intervention arm |
| BG001 | Fluoxetine | Active control arm |
| BG002 |
| 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 | Time to Treatment Failure | Time to either all-cause-discontinuation or need to add another psychotropic agent | Data was not collected | Posted | 24 weeks |
|
|
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 | Intervention arm | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christoph Correll | Northwell Health | 718-470 | 7000 | ccorrell@northwell.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 | Mar 9, 2016 | Oct 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 2, 2016 | Oct 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Fluoxetine | Drug | see arm description |
|
|
| 24 weeks |
| Change in Social and Role Functioning Scores | Change in social and role functioning scores (range: 0-10, higher sores = better outcome) | 24 weeks |
| Subjective Well-being Questionnaire | Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being) | 24 weeks |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treatment Failure | Count of Participants | Participants |
|
|
| Secondary | Change in Prodromal Symptoms (SOPS) Total Scores | Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse) | Data was not collected | Posted | 24 weeks |
|
|
| Secondary | Number of Patients With Specific Adverse Effects | Number of patients with any adverse effects based on spontaneous report | Data was not collected | Posted | 24 weeks |
|
|
| Secondary | Change in Social and Role Functioning Scores | Change in social and role functioning scores (range: 0-10, higher sores = better outcome) | Data was not collected | Posted | 24 weeks |
|
|
| Secondary | Subjective Well-being Questionnaire | Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being) | Data was not collected | Posted | 24 weeks |
|
|
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Fluoxetine | Active control arm | 0 | 5 | 0 | 5 | 0 | 5 |
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |