The Role of Antidepressants or Antipsychotics in Preventing Psychosis

This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.

Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.

Study Overview

• Status: Withdrawn
• Conditions: Psychotic Disorder
• Intervention / Treatment: Drug: Antidepressant; Drug: Antipsychotic

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 12-25 years of age (inclusive)
• Able to understand and speak English
• Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe

Exclusion Criteria:

• Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
• Current psychosis
• Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
• Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
• Current stimulant treatment
• Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain
• Estimated intelligence quotient < 70

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antidepressant; Fluoxetine	Drug: Antidepressant; Other Names: Fluoxetine
Active Comparator: Antipsychotic; Aripiprazole	Drug: Antipsychotic; Other Names: Aripiprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attenuated positive, negative and general psychiatric symptoms	To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social and role functioning	To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.	6 months
Time to all-cause discontinuation.	To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.	6 months
Adverse effects	To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.	6 months

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborators: The Zucker Hillside Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: November 1, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 9, 2012

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 23, 2014
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Aripiprazole; Fluoxetine; Antidepressive Agents; Antipsychotic Agents
• Other Study ID Numbers: 12-094