Trial Outcomes & Findings for Psychosis: Early Detection, Intervention and Prevention (NCT NCT01597141)

Results Overview

Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months

Results posted on

2016-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Family-aided ACT The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	Enhanced Treatment In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Psychosis: Early Detection, Intervention and Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Family-aided ACT n=50 Participants The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	Enhanced Treatment n=50 Participants In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention	Total n=100 Participants Total of all reporting groups
Age, Continuous	16.48 years STANDARD_DEVIATION 3.07 • n=5 Participants	16.12 years STANDARD_DEVIATION 2.75 • n=7 Participants	16.3 years STANDARD_DEVIATION 2.9 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	50 participants n=5 Participants	46 participants n=7 Participants	96 participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Global Assessment of Functioning (GAF)	40.16 units on GAF scale STANDARD_DEVIATION 13.93 • n=5 Participants	36.39 units on GAF scale STANDARD_DEVIATION 10.35 • n=7 Participants	39.7 units on GAF scale STANDARD_DEVIATION 12.1 • n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months

Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.

Outcome measures

Outcome measures
Measure	Family-aided ACT n=50 Participants The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	Enhanced Treatment n=50 Participants In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Onset of Psychosis	10 percentage of sample converting	14 percentage of sample converting

SECONDARY outcome

Timeframe: 24 months

Population: 15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study.

Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.

Outcome measures

Outcome measures
Measure	Family-aided ACT n=35 Participants The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	Enhanced Treatment n=34 Participants In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Functioning	59.83 units on GAF scale Standard Deviation 16.38	54.68 units on GAF scale Standard Deviation 13.38

Adverse Events

Family-aided Assertive Community Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Standard Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Family-aided Assertive Community Treatment n=50 participants at risk The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	Enhanced Standard Treatment n=50 participants at risk In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
Psychiatric disorders Suicide	2.0% 1/50 • Number of events 1	2.0% 1/50 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

William R. McFarlane, M.D.

Maine Medical Center Research Institute

Phone: 207-662-4348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place