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| Sponsors and Collaborators: |
Maine Medical Center Robert Wood Johnson Foundation |
|---|---|
| Information provided by: | Maine Medical Center |
| ClinicalTrials.gov Identifier: | NCT00531518 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Bipolar Disorder Depression Psychotic Disorders |
Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine Behavioral: Psychoeducational multifamily group treatment Behavioral: Supported employment and education |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Early Detection and Intervention for the Prevention of Psychosis Project |
| Estimated Enrollment: | 900 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
This is the control arm. Participants will be offered only case management.
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2: Experimental
This is the experimental intervention arm for high-risk-for-psychosis participants.
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Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
Oral, daily, generally at lower than manufacturer's recommendations
Behavioral: 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
Behavioral: Supported employment and education
Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
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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.
Eligibility| Ages Eligible for Study: | 12 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: William R. McFarlane, M.D. | 207-662-2091 | mcfarw@mmc.org |
| Contact: William L. Cook, Ph.D | 207-662-2091 | cookw@mmc.org |
| United States, California | |
| University of California-Davis, Imaging Research Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Cameron Carter, M.D. 916-734-3230 cameron.carter@ucdmc.ucdavis.edu | |
| Contact: Daniel Ragland, Ph.D. 916.734.5802 jdragland@ucdavis.edu | |
| Principal Investigator: Cameron Carter, M.D. | |
| United States, Maine | |
| Portland Identification and Early Referral Program | Recruiting |
| Portland, Maine, United States, 04102 | |
| Contact: William McFarlane, M.D. 207-662-2091 mcfarw@mmc.org | |
| Contact: William L. Cook, Ph.D. 207-662-2091 cookw@mmc.org | |
| Principal Investigator: William R. McFarlane, M.D. | |
| United States, Michigan | |
| Washtenaw County | Recruiting |
| Ann Arbor, Michigan, United States, 48108 | |
| Contact: Karen Milner, M.D. 734-936-5879 kmilner@umich.edu | |
| Contact: Elizabeth Spring, R.N. 734.368.8794 springe@washtenaw.org | |
| Principal Investigator: Karen Milner, M.D. | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| Contact: Steven Adelsheim, M.D. 505-272-2223 sadelsheim@salud.unm.edu | |
| Principal Investigator: Steven Adelsheim, M.D. | |
| United States, New York | |
| Zucker Hillside Hosptial | Recruiting |
| Glen Oaks, New York, United States, 11004 | |
| Contact: Barbara Cornblatt, Ph.D. 718-470-8133 cornblat@lij.edu | |
| Contact: Christopher Smith, Ph.D 718.470.8286 csmith@lij.edu | |
| Principal Investigator: Barbara Cornblatt, Ph.D. | |
| United States, Oregon | |
| Mid-Valley Behavioral Care Network | Recruiting |
| Salem, Oregon, United States, 97301 | |
| Contact: Rod Calkins, Ph.D. 503-585-4978 rcalkins@co.marion.or.us | |
| Contact: Tamara Sale 503.361.2796 tsale@mvbcn.org | |
| Principal Investigator: Rod Calkins, Ph.D. | |
| Principal Investigator: | William R. McFarlane, M.D. | Maine Medical Center |
More Information
| Responsible Party: | Maine Medical Center ( James Donovan, Assoc V.P. Medical Affairs ) |
| Study ID Numbers: | 58920, RWJF #58920 |
| Study First Received: | September 18, 2007 |
| Last Updated: | May 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00531518 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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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 |
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Tranquilizing Agents Depression Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Calcium Channel Blockers Cardiovascular Agents Depressive Disorder, Major Antipsychotic Agents Depressive Disorder Behavioral Symptoms Fluoxetine |
Schizophrenia Calcium, Dietary Affective Disorders, Psychotic Mental Disorders Bupropion Mood Disorders Lamotrigine Sertraline Psychotic Disorders Aripiprazole Anticonvulsants Schizophrenia and Disorders with Psychotic Features |
|
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Schizophrenia Membrane Transport Modulators Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features Disease |
Depression Tranquilizing Agents Bipolar Disorder Central Nervous System Depressants Cardiovascular Agents Depressive Disorder Antipsychotic Agents Pharmacologic Actions Behavioral Symptoms Lamotrigine Mood Disorders Central Nervous System Agents Anticonvulsants |
