Attenuated Psychosis SyndromePhase 4FACTNCT02357849
Fluoxetine vs Aripiprazole Comparative Trial (FACT)
A Phase 4 study testing Aripiprazole and Fluoxetine in people with Attenuated Psychosis Syndrome, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Attenuated Psychosis Syndrome
- What is being tested?
- Aripiprazole and Fluoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 4 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
About this study
Official title: The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)
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.
Read the detailed description
To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects
- Conditions
- Attenuated Psychosis Syndrome
- Being tested
- Aripiprazole, Fluoxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
see arm description
FluoxetineDrug
Also called Prozac
see arm description
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Aripiprazole |
| 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). Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure
Time to either all-cause-discontinuation or need to add another psychotropic agent
Measured: 24 weeks
Secondary outcomes (4)
Change in Prodromal Symptoms (SOPS) Total Scores
Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse)
Measured: 24 weeks
Number of Patients With Specific Adverse Effects
Number of patients with any adverse effects based on spontaneous report
Measured: 24 weeks
Change in Social and Role Functioning Scores
Change in social and role functioning scores (range: 0-10, higher sores = better outcome)
Measured: 24 weeks
Subjective Well-being Questionnaire
Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJul 2014
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attenuated Psychosis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph U. Correll, MD, Northwell Health
- Investigators
- Christoph U Correll, MD, Principal investigator, North Shore LIJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357849
- Sponsor's protocol ID
- 11-199
- Acronym
- FACT
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2014
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)
- ClinicalTrials.gov ID
- NCT02357849
- Acronym / sponsor ID
- FACT / 11-199
- Conditions
- Attenuated Psychosis Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 15 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Active comparator | Drug: AripiprazoleTo 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 | Drug: FluoxetineTo 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). |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: Abilifysee arm description | Drug | Aripiprazole |
| FluoxetineAlso: Prozacsee arm description | Drug | Fluoxetine |
Primary outcome
Time to Treatment Failure
Time frame: 24 weeks
Time to either all-cause-discontinuation or need to add another psychotropic agent
4 secondary outcomes
Change in Prodromal Symptoms (SOPS) Total Scores
Time frame: 24 weeks
Number of Patients With Specific Adverse Effects
Time frame: 24 weeks
Change in Social and Role Functioning Scores
Time frame: 24 weeks
Subjective Well-being Questionnaire
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph U Correll, MD principal investigator
North Shore LIJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole and Fluoxetine in people with Attenuated Psychosis Syndrome, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.