The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Psychotic Disorder Clinical Trial

Official title:

The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01724372
• Other study ID #: 12-094
• Status: Withdrawn
• Phase: N/A
• First received: November 1, 2012
• Last updated: May 23, 2014
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2012
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders

Intervention

Drug:
• Antidepressant

• Antipsychotic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	The Zucker Hillside Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attenuated positive, negative and general psychiatric symptoms	To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse effects	To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.	6 months	Yes