SchizophreniaEDIPPNCT00531518
Early Detection and Intervention for the Prevention of Psychosis
A study testing aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine, Psychoeducational multifamily group treatment and Supported employment and education in people with Schizophrenia and Bipolar Disorder, run by MaineHealth at 6 sites in United States.
Trial summary
EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Depression
- What is being tested?
- aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine, Psychoeducational multifamily group treatment and Supported employment and education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2007to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects in the age range of 12-25 and living in the experimental catchment area may be enrolled in the EDIPP study based on meeting at least one of the inclusion requirements AND none of the exclusion criteria;
- Screening process indicates symptoms equivalent to a minimum rating of '1' on at least one positive symptom of psychosis;
- Screening process indicates a likely family history of first degree relative with psychotic illness plus a deterioration in functioning equivalent to a 30% drop in functioning score over the past year; OR
- Screening process indicates a likely history of schizotypal personality disorder plus a deterioration in functioning equivalent to a 30% drop in functioning over the past year.
Who cannot join
- Outside the age range of 12 to 25 years;
- History of intelligence quotient (IQ) below 70 (based on school records, not tested at PIER);
- More than one month duration of psychosis (guided by the criteria of at least one 6 on the Positive Symptom sub-scale of the Scale of Positive Symptoms (SOPS);
- History of previous psychotic episode, whether or not treatment was received;
- Taken antipsychotic medication for more than 30 days at a therapeutic dose for psychotic symptoms;
- Either the young person being screened for the study or both parents do not speak proficient English;
- Female is pregnant at baseline (inquired on the screening interview); AND
- Subject is a prisoner.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of New Mexico
Albuquerque, New Mexico, 87131-0001
Washtenaw County
Ann Arbor, Michigan, 48108
Zucker Hillside Hosptial
Glen Oaks, New York, 11004
Portland Identification and Early Referral Program
Portland, Maine, 04102
University of California-Davis, Imaging Research Center
Sacramento, California, 95817
Mid-Valley Behavioral Care Network
Salem, Oregon, 97301
About this study
Official title: Early Detection and Intervention for the Prevention of Psychosis Project
EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.
Read the detailed description
The study is structured as a cutoff, regression discontinuity design, in which lower risk-for-psychosis participants will not be treated by protocol but followed up for two years. Those at higher risk will be treated with anti-psychotic, antidepressant and mood stabilizing medications by symptom indications, and systematically provided psychoeducational multifamily group treatment, supported education and employment, and intensive clinical case management, using key elements of Assertive Community Treatment. Both arms of the study will be followed for two years and assessed at 6, 12, and 24 months. Outcome measures include rates of conversion to psychosis, relapse of psychosis, development of psychotic disorder diagnoses, levels of positive, negative and general symptoms, social and vocational functioning, family functioning, and neurocognitive functioning.
The six sites include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; Albuquerque, New Mexico and Glen Oaks, New York.
In addition to symptomatic and functional outcomes, impact on incidence of psychotic disorders, including schizophrenia, will be assessed, as will cost-benefit effects.
- Conditions
- Schizophrenia, Bipolar Disorder, Depression, Psychotic Disorders
- Being tested
- aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine, Psychoeducational multifamily group treatment, Supported employment and education
- Keywords
- Schizophrenia, Bipolar disorder, Psychosis, Prodromal psychosis, Family psychoeducation, Supported education, Supported employment, Ulra-high-risk for psychosis, Major depression, Bipolar disorder, with psychotic features, Major depression, with psychotic features, Attenuated, prodromal psychotic symptoms
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depression, Psychotic Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigineDrug
Also called Abilify, Prozac, Welbutrin, Zoloft
Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatmentBehavioural
Also called Family psychoeducation,, Family behavioral therapy, Multiple family group therapy
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 educationBehavioural
Also called Supported employment, Supported education
Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 | Experimental | 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 . Receives: Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine; Behavioral: Psychoeducational multifamily group treatment; Behavioral: Supported employment and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic Symptoms
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, William McFarlane, MaineHealth
- Investigators
- William R. McFarlane, M.D., Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531518
- Sponsor's protocol ID
- 58920
- Other IDs
- RWJF #58920
- Acronym
- EDIPP
- Status last verified
- Jul 2016
- First submitted
- 18 Sep 2007
- Last updated
- 15 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Currently, on request, data will be shared with legitimate organizations for specific analyses approved by the PI and the Maine Medical Center Institutional Review Board.
Publications
Lynch S, McFarlane WR, Joly B, Adelsheim S, Auther A, Cornblatt BA, Migliorati M, Ragland JD, Sale T, Spring E, Calkins R, Carter CS, Jaynes R, Taylor SF, Downing D. Early Detection, Intervention and Prevention of Psychosis Program: Community Outreach and Early Identification at Six U.S. Sites. Psychiatr Serv. 2016 May 1;67(5):510-6. doi: 10.1176/appi.ps.201300236. Epub 2016 Jan 14.
PubMed 26766751McFarlane WR, Levin B, Travis L, Lucas FL, Lynch S, Verdi M, Williams D, Adelsheim S, Calkins R, Carter CS, Cornblatt B, Taylor SF, Auther AM, McFarland B, Melton R, Migliorati M, Niendam T, Ragland JD, Sale T, Salvador M, Spring E. Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial. Schizophr Bull. 2015 Jan;41(1):30-43. doi: 10.1093/schbul/sbu108. Epub 2014 Jul 26.
PubMed 25065017
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Intervention for the Prevention of Psychosis Project
- ClinicalTrials.gov ID
- NCT00531518
- Acronym / sponsor ID
- EDIPP / 58920
- Conditions
- Schizophrenia, Bipolar Disorder, Depression, Psychotic Disorders
- Keywords
- Schizophrenia, Bipolar disorder, Psychosis, Prodromal psychosis, Family psychoeducation, Supported education, Supported employment, Ulra-high-risk for psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Oct 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.
Detailed description
The study is structured as a cutoff, regression discontinuity design, in which lower risk-for-psychosis participants will not be treated by protocol but followed up for two years. Those at higher risk will be treated with anti-psychotic, antidepressant and mood stabilizing medications by symptom indications, and systematically provided psychoeducational multifamily group treatment, supported education and employment, and intensive clinical case management, using key elements of Assertive Community Treatment. Both arms of the study will be followed for two years and assessed at 6, 12, and 24 months. Outcome measures include rates of conversion to psychosis, relapse of psychosis, development of psychotic disorder diagnoses, levels of positive, negative and general symptoms, social and vocational functioning, family functioning, and neurocognitive functioning.
The six sites include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; Albuquerque, New Mexico and Glen Oaks, New York.
In addition to symptomatic and functional outcomes, impact on incidence of psychotic disorders, including schizophrenia, will be assessed, as will cost-benefit effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 | Experimental | Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine, Behavioral: Psychoeducational multifamily group treatment, Behavioral: Supported employment and educationThis 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 . |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects in the age range of 12-25 and living in the experimental catchment area may be enrolled in the EDIPP study based on meeting at least one of the inclusion requirements AND none of the exclusion criteria;
- Screening process indicates symptoms equivalent to a minimum rating of '1' on at least one positive symptom of psychosis;
- Screening process indicates a likely family history of first degree relative with psychotic illness plus a deterioration in functioning equivalent to a 30% drop in functioning score over the past year; OR
- Screening process indicates a likely history of schizotypal personality disorder plus a deterioration in functioning equivalent to a 30% drop in functioning over the past year.
Key exclusion criteria (8 listed)
- Outside the age range of 12 to 25 years;
- History of intelligence quotient (IQ) below 70 (based on school records, not tested at PIER);
- More than one month duration of psychosis (guided by the criteria of at least one 6 on the Positive Symptom sub-scale of the Scale of Positive Symptoms (SOPS);
- History of previous psychotic episode, whether or not treatment was received;
- Taken antipsychotic medication for more than 30 days at a therapeutic dose for psychotic symptoms;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aripiprazole; fluoxetine; bupropion; sertraline; lamotrigineAlso: Abilify, Prozac, Welbutrin, ZoloftOral, daily, generally at lower than manufacturer's recommendations | Drug | Family-aided Assertive Community Treatment |
| Psychoeducational multifamily group treatmentAlso: Family psychoeducation,, Family behavioral therapy, Multiple family group therapyFamilies 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 | Behavioural | Family-aided Assertive Community Treatment |
| Supported employment and educationAlso: Supported employment, Supported educationParticipants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals. | Behavioural | Family-aided Assertive Community Treatment |
Primary outcome
Psychotic Symptoms
Time frame: two years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26766751Lynch S, McFarlane WR, Joly B, Adelsheim S, Auther A, Cornblatt BA, Migliorati M, Ragland JD, Sale T, Spring E, Calkins R, Carter CS, Jaynes R, Taylor SF, Downing D. Early Detection, Intervention and Prevention of Psychosis Program: Community Outreach and Early Identification at Six U.S. Sites. Psychiatr Serv. 2016 May 1;67(5):510-6. doi: 10.1176/appi.ps.201300236. Epub 2016 Jan 14.
- Results publication: PubMed 25065017McFarlane WR, Levin B, Travis L, Lucas FL, Lynch S, Verdi M, Williams D, Adelsheim S, Calkins R, Carter CS, Cornblatt B, Taylor SF, Auther AM, McFarland B, Melton R, Migliorati M, Niendam T, Ragland JD, Sale T, Salvador M, Spring E. Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial. Schizophr Bull. 2015 Jan;41(1):30-43. doi: 10.1093/schbul/sbu108. Epub 2014 Jul 26.
- Describes the orientation of the program and early signs of psychosisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Currently, on request, data will be shared with legitimate organizations for specific analyses approved by the PI and the Maine Medical Center Institutional Review Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William R. McFarlane, M.D. principal investigator
MaineHealth
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine, Psychoeducational multifamily group treatment and Supported employment and education in people with Schizophrenia and Bipolar Disorder, run by MaineHealth at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychotic Symptoms (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00531518, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.