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Fluoxetine vs Aripiprazole Comparative Trial (FACT) (FACT)

Primary Purpose

Attenuated Psychosis Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Fluoxetine
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attenuated Psychosis Syndrome

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aripiprazole

Fluoxetine

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Time to treatment failure
Time to either all-cause-discontinuation or need to add another psychotropic agent

Secondary Outcome Measures

Change in Prodromal Symptoms (SOPS) total scores
Number of patients with specific adverse effects
Change in social and role functioning scores
Subjective well-being questionnaire

Full Information

First Posted
September 30, 2014
Last Updated
April 4, 2022
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT02357849
Brief Title
Fluoxetine vs Aripiprazole Comparative Trial (FACT)
Acronym
FACT
Official Title
The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attenuated Psychosis Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Fluoxetine
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
see arm description
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
see arm description
Primary Outcome Measure Information:
Title
Time to treatment failure
Description
Time to either all-cause-discontinuation or need to add another psychotropic agent
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Prodromal Symptoms (SOPS) total scores
Time Frame
24 weeks
Title
Number of patients with specific adverse effects
Time Frame
24 weeks
Title
Change in social and role functioning scores
Time Frame
24 weeks
Title
Subjective well-being questionnaire
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph U Correll, MD
Organizational Affiliation
North Shore LIJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

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Fluoxetine vs Aripiprazole Comparative Trial (FACT)

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