Trial Outcomes & Findings for Early Detection and Intervention for the Prevention of Psychosis (NCT NCT00531518)
NCT ID: NCT00531518
Last Updated: 2016-08-15
Results Overview
Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
292 participants
Primary outcome timeframe
two years
Results posted on
2016-08-15
Participant Flow
Participant milestones
| Measure |
Control Group
This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
|
Family-aided Assertive Community Treatment
This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
205
|
|
Overall Study
COMPLETED
|
55
|
134
|
|
Overall Study
NOT COMPLETED
|
32
|
71
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Detection and Intervention for the Prevention of Psychosis
Baseline characteristics by cohort
| Measure |
Control Group
n=87 Participants
This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
|
Experimental Intervention
n=205 Participants
This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.23 years
STANDARD_DEVIATION 3.18 • n=5 Participants
|
16.40 years
STANDARD_DEVIATION 3.30 • n=7 Participants
|
16.35 years
STANDARD_DEVIATION 3.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
205 participants
n=7 Participants
|
292 participants
n=5 Participants
|
|
Psychotic symptoms
|
4.15 units on a scale
STANDARD_DEVIATION 1.76 • n=5 Participants
|
11.99 units on a scale
STANDARD_DEVIATION 3.42 • n=7 Participants
|
9.65 units on a scale
STANDARD_DEVIATION 4.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: two yearsPsychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.
Outcome measures
| Measure |
Control
n=87 Participants
This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
|
Family-aided Assertive Community Treatment
n=205 Participants
This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
|
|---|---|---|
|
Psychotic Symptoms
|
9.2 units on a scale
Standard Deviation 1.0
|
6.7 units on a scale
Standard Deviation 0.4
|
Adverse Events
Control Group
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Family-aided Assertive Community Treatment
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=87 participants at risk
This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
|
Family-aided Assertive Community Treatment
n=205 participants at risk
This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
|
|---|---|---|
|
Psychiatric disorders
suicide
|
1.1%
1/87 • Number of events 1 • Over 24 months
|
0.00%
0/205 • Over 24 months
|
Other adverse events
| Measure |
Control Group
n=87 participants at risk
This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
|
Family-aided Assertive Community Treatment
n=205 participants at risk
This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
|
|---|---|---|
|
Psychiatric disorders
Negative events
|
21.8%
19/87 • Number of events 19 • Over 24 months
|
24.9%
51/205 • Number of events 51 • Over 24 months
|
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