The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01724372

Enrollment

Registered

2012-11-09

Start date

2012-10-31

Completion date

2014-05-31

Last updated

2014-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorder

Brief 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.

Interventions

DRUGAntidepressant

DRUGAntipsychotic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 25 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026