N/A N=404 Randomized Single-blind Treatment

An Integrated Program for the Treatment of First Episode of Psychosis

Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorder · Brief Psychotic Disorder · Psychotic Disorder NOS

Bottom Line

View on ClinicalTrials.gov: NCT01321177 ↗

Enrolled (actual)

404

Serious AEs

33.9%

Results posted

Oct 2021

Primary outcome: Primary: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time — 51.25; 55.13; 59.15; 60.08 score on a scale — p=0.0145

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Integrated Treatment (Behavioral); Community Care (Behavioral)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: Northwell Health
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time	51.25; 55.13; 59.15; 60.08; 62.42; 62.12	0.0145 sig
SECONDARY Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score	77.54; 74.69; 70.38; 69.70; 67.41; 67.63	—
SECONDARY Calgary Depression Scale	4.71; 4.52; 3.72; 3.93; 3.31; 3.68	—
SECONDARY Service Use Rating Form (SURF)	4.53; 3.67	—

Summary

The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.

Eligibility Criteria

Inclusion Criteria

Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of:
schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder NOS
Any duration of untreated psychosis
Any ethnicity
Ability to participate in research assessments in English
Ability to provide fully informed consent (assent for those under age 18)

Exclusion Criteria

Inability to understand what research participation entails or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent
More than 4 months of prior cumulative treatment with antipsychotic medications
Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic disorder
Current psychotic disorder due to a general medical condition
Current neurological disorders that would affect diagnosis or prognosis. These would include, but are not limited to seizure disorders, dementing or degenerative disorders, lesions or substantial congenital abnormalities. In most cases, disorders such as headache disorders would not require protocol exclusion
Clinically significant head trauma
Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01321177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.