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The Role of Antidepressants or Antipsychotics in Preventing Psychosis

S

St. Luke's-Roosevelt Hospital Center

Status

Withdrawn

Conditions

Psychotic Disorder

Treatments

Drug: Antidepressant
Drug: Antipsychotic

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 25 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups

Antidepressant
Experimental group
Description:
Fluoxetine
Treatment:
Drug: Antidepressant
Antipsychotic
Active Comparator group
Description:
Aripiprazole
Treatment:
Drug: Antipsychotic

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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