Attenuated Psychosis Syndrome
Conditions
Brief summary
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.
Detailed description
To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects
Interventions
DRUGAripiprazole
see arm description
DRUGFluoxetine
see arm description
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* consent obtained from patients and their parents (assent for patients under 18); * age 12-25 years (inclusive); * English-speaking; * at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.
Exclusion criteria
* lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features; * current psychosis (any positive symptom SOPS score of 6, i.e., extreme); * current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features; * current stimulant treatment; * history of neurological, neuroendocrine or other medical condition known to affect the brain; * any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine; * past or current substance dependence; sunstance abuse within the last 4 weeks; * IQ \< 70.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure | 24 weeks | Time to either all-cause-discontinuation or need to add another psychotropic agent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prodromal Symptoms (SOPS) Total Scores | 24 weeks | Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse) |
| Number of Patients With Specific Adverse Effects | 24 weeks | Number of patients with any adverse effects based on spontaneous report |
| Change in Social and Role Functioning Scores | 24 weeks | Change in social and role functioning scores (range: 0-10, higher sores = better outcome) |
| Subjective Well-being Questionnaire | 24 weeks | Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being) |
Countries
United States
Participant flow
Recruitment details
outpatient clinic
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole Intervention arm | 4 |
| Fluoxetine Active control arm | 5 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Aripiprazole | Fluoxetine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.5 years STANDARD_DEVIATION 1.3 | 16.0 years STANDARD_DEVIATION 1.7 | 15.8 years STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
| Treatment Failure | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
Time to Treatment Failure
Time to either all-cause-discontinuation or need to add another psychotropic agent
Time frame: 24 weeks
Population: Data was not collected
Secondary
Change in Prodromal Symptoms (SOPS) Total Scores
Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse)
Time frame: 24 weeks
Population: Data was not collected
Secondary
Change in Social and Role Functioning Scores
Change in social and role functioning scores (range: 0-10, higher sores = better outcome)
Time frame: 24 weeks
Population: Data was not collected
Secondary
Number of Patients With Specific Adverse Effects
Number of patients with any adverse effects based on spontaneous report
Time frame: 24 weeks
Population: Data was not collected
Secondary
Subjective Well-being Questionnaire
Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being)
Time frame: 24 weeks
Population: Data was not collected