NCT02357849

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 15, 2023

Completed
Last Updated

November 15, 2023

Status Verified

October 1, 2023

Enrollment Period

7.8 years

First QC Date

September 30, 2014

Results QC Date

October 5, 2023

Last Update Submit

October 27, 2023

Conditions

Attenuated Psychosis Syndrome

Outcome Measures

Primary Outcomes (1)

  • Time to Treatment Failure

    Time to either all-cause-discontinuation or need to add another psychotropic agent

    24 weeks

Secondary Outcomes (4)

  • Change in Prodromal Symptoms (SOPS) Total Scores

    24 weeks

  • Number of Patients With Specific Adverse Effects

    24 weeks

  • Change in Social and Role Functioning Scores

    24 weeks

  • Subjective Well-being Questionnaire

    24 weeks

Study Arms (2)

Aripiprazole

ACTIVE COMPARATOR

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

Fluoxetine

ACTIVE COMPARATOR

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

Interventions

AripiprazoleDRUG

see arm description

Also known as: Abilify
Aripiprazole
FluoxetineDRUG

see arm description

Also known as: Prozac
Fluoxetine

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Interventions

AripiprazoleFluoxetine

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Dr. Christoph Correll
Organization
Northwell Health
ccorrell@northwell.edu
718-470

Study Officials

  • Christoph U Correll, MD

    North Shore LIJ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Molecular Medicine Hofstra North Shore LIJ School of Medicine

Study Record Dates

First Submitted

September 30, 2014

First Posted

February 6, 2015

Study Start

July 1, 2014

Primary Completion

April 4, 2022

Study Completion

April 4, 2022

Last Updated

November 15, 2023

Results First Posted

November 15, 2023

Record last verified: 2023-10

Locations

US(1)