Prodromal SchizophreniaEDIPNCT01597141
Psychosis: Early Detection, Intervention and Prevention
A study testing Family-aided Assertive Community Treatment and Enhanced standard treatment in people with Prodromal Schizophrenia and Psychotic Disorders, run by MaineHealth at 1 site in United States.
Trial summary
The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Prodromal Schizophrenia, Psychotic Disorders, Severe Bipolar Disorder With Psychotic Features
- What is being tested?
- Family-aided Assertive Community Treatment and Enhanced standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Dec 2014
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Prodromal psychotic symptoms
- Age 12-35
- In catchment area (greater Portland, Maine)
Who cannot join
- Previous or current psychotic episode
- IQ less than 70
- Outside catchment area
- Toxic psychosis
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.
Read the detailed description
The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.
The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.
- Conditions
- Prodromal Schizophrenia, Psychotic Disorders, Severe Bipolar Disorder With Psychotic Features, Severe Major Depression With Psychotic Features
- Being tested
- Family-aided Assertive Community Treatment, Enhanced standard treatment
- Keywords
- Prodromal, Schizophrenia, Psychosis, Family psychoeducation, Assertive community treatment, Supported employment, Supported education
- Medical subject headings
- Schizotypal Personality Disorder, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-aided Assertive Community TreatmentBehavioural
The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Enhanced standard treatmentBehavioural
In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
| Study group | Role | What they receive |
|---|---|---|
| Family-aided Assertive Community Treatment | Experimental | The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Receives: Behavioral: Family-aided Assertive Community Treatment |
| Enhanced standard treatment | Active comparator | In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Receives: Behavioral: Enhanced standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Psychosis
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.
Measured: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months
Secondary outcomes (1)
Functioning
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2003
- Primary completionSep 2014
- Study completionDec 2014
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 (3)Papers the sponsor has linked to this study.
- Other trials for Prodromal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Harvard University, University of California, Irvine
- Responsible party
- Principal investigator, William McFarlane, MaineHealth
- Investigators
- William R McFarlane, M.D., Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597141
- Sponsor's protocol ID
- 1R01MH065367-01A1
- Acronym
- EDIP
- Status last verified
- Jan 2016
- First submitted
- 9 May 2012
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McFarlane WR, Susser E, McCleary R, Verdi M, Lynch S, Williams D, McKeague IW. Reduction in incidence of hospitalizations for psychotic episodes through early identification and intervention. Psychiatr Serv. 2014 Oct;65(10):1194-200. doi: 10.1176/appi.ps.201300336.
PubMed 24632857Woodberry KA, McFarlane WR, Giuliano AJ, Verdi MB, Cook WL, Faraone SV, Seidman LJ. Change in neuropsychological functioning over one year in youth at clinical high risk for psychosis. Schizophr Res. 2013 May;146(1-3):87-94. doi: 10.1016/j.schres.2013.01.017. Epub 2013 Feb 22.
PubMed 23434505McFarlane WR, Cook WL, Downing D, Verdi MB, Woodberry KA, Ruff A. Portland identification and early referral: a community-based system for identifying and treating youths at high risk of psychosis. Psychiatr Serv. 2010 May;61(5):512-5. doi: 10.1176/appi.ps.61.5.512.
PubMed 20439374
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosis: Early Detection, Intervention and Prevention
- ClinicalTrials.gov ID
- NCT01597141
- Acronym / sponsor ID
- EDIP / 1R01MH065367-01A1
- Conditions
- Prodromal Schizophrenia, Psychotic Disorders, Severe Bipolar Disorder With Psychotic Features, Severe Major Depression With Psychotic Features
- Keywords
- Prodromal, Schizophrenia, Psychosis, Family psychoeducation, Assertive community treatment, Supported employment, Supported education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- Columbia University, Harvard University, University of California, Irvine
- Study start
- May 2003
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Posted 8 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.
Detailed description
The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.
The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-aided Assertive Community Treatment | Experimental | Behavioral: Family-aided Assertive Community TreatmentThe experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. |
| Enhanced standard treatment | Active comparator | Behavioral: Enhanced standard treatmentIn this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Prodromal psychotic symptoms
- Age 12-35
- In catchment area (greater Portland, Maine)
Key exclusion criteria (4 listed)
- Previous or current psychotic episode
- IQ less than 70
- Outside catchment area
- Toxic psychosis
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 |
|---|---|---|
| Family-aided Assertive Community TreatmentThe experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. | Behavioural | Family-aided Assertive Community Treatment |
| Enhanced standard treatmentIn this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention | Behavioural | Enhanced standard treatment |
Primary outcome
Onset of Psychosis
Time frame: 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.
1 secondary outcome
Functioning
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24632857McFarlane WR, Susser E, McCleary R, Verdi M, Lynch S, Williams D, McKeague IW. Reduction in incidence of hospitalizations for psychotic episodes through early identification and intervention. Psychiatr Serv. 2014 Oct;65(10):1194-200. doi: 10.1176/appi.ps.201300336.
- Background: PubMed 23434505Woodberry KA, McFarlane WR, Giuliano AJ, Verdi MB, Cook WL, Faraone SV, Seidman LJ. Change in neuropsychological functioning over one year in youth at clinical high risk for psychosis. Schizophr Res. 2013 May;146(1-3):87-94. doi: 10.1016/j.schres.2013.01.017. Epub 2013 Feb 22.
- Results publication: PubMed 20439374McFarlane WR, Cook WL, Downing D, Verdi MB, Woodberry KA, Ruff A. Portland identification and early referral: a community-based system for identifying and treating youths at high risk of psychosis. Psychiatr Serv. 2010 May;61(5):512-5. doi: 10.1176/appi.ps.61.5.512.
- Describes risk factors for psychosis, current scientific understanding of psychosis and means of accessing servicesLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-aided Assertive Community Treatment and Enhanced standard treatment in people with Prodromal Schizophrenia and Psychotic Disorders, run by MaineHealth at 1 site 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 3 inclusion and 4 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 Feb 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?
Onset of Psychosis (time frame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months). 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 NCT01597141, which also lists 3 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 8 Feb 2016.