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Fluoxetine vs Aripiprazole Comparative Trial (FACT) (FACT)

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ClinicalTrials.gov Identifier: NCT02357849
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Christoph U. Correll, MD, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Attenuated Psychosis Syndrome Drug: Aripiprazole Drug: Fluoxetine Phase 4

Detailed Description:
To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)
Study Start Date : July 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aripiprazole
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).
Drug: Aripiprazole
see arm description
Other Name: Abilify

Active Comparator: Fluoxetine
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).
Drug: Fluoxetine
see arm description
Other Name: Prozac




Primary Outcome Measures :
  1. Time to treatment failure [ Time Frame: 24 weeks ]
    Time to either all-cause-discontinuation or need to add another psychotropic agent


Secondary Outcome Measures :
  1. Change in Prodromal Symptoms (SOPS) total scores [ Time Frame: 24 weeks ]
  2. Number of patients with specific adverse effects [ Time Frame: 24 weeks ]
  3. Change in social and role functioning scores [ Time Frame: 24 weeks ]
  4. Subjective well-being questionnaire [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357849


Contacts
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Contact: Christoph U Correll, MD 718-470-4812 ccorrell@nshs.edu
Contact: Michael Birnbaum, MD 718-470-8305 Mbirnbaum@nshs.edu

Locations
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United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Contact: Christoph U Correll, MD    718-470-4812    ccorrell@nshs.edu   
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Christoph U Correll, MD North Shore LIJ

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Responsible Party: Christoph U. Correll, MD, Professor of Psychiatry and Molecular Medicine Hofstra North Shore LIJ School of Medicine, Northwell Health
ClinicalTrials.gov Identifier: NCT02357849     History of Changes
Other Study ID Numbers: 11-199
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Aripiprazole
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Fluoxetine
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors