Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial
NCT ID: NCT01936220
Last Updated: 2013-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
1997-09-30
2016-02-29
Brief Summary
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Methods: A three conditions randomized trial with a duration of five years
Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic episode of schizophrenia or related disorder
Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent groups (ST+P) and Treatment As Usual (TAU).
Outcome-measures: cumulative relapse rates and time to first relapse after first remission. Secondary outcome measure: social functioning.
Statistical analysis: cumulative relapse rates using life-table methods. The effect of the three interventions on time to first relapse after remission will be compared using Cox regression analysing intention to treat (ITT) grouping.
Detailed Description
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In this study we examine both the symptomatic (relapse) and psychosocial outcome of a three armed five year randomized trial in the initial phase of schizophrenia.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Continuity of specialized care
Continuity of specialized inpatient and outpatient care (relapse prevention)
Continuity of specialized care
Continuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).
Continuity of specialized care and parent groups
Continuity of specialized care combined with Parent groups
Continuity of specialized care
Continuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).
Parent groups combined with Continuity of Specialized care
Approximately fifty parent group therapy sessions will be held in a flexible way over a 60 month period. Each parent group was run by two experienced family therapists.
Treatment as usual
Discontinuity of care, relapse prevention as usual
Discontinuity of care, non specialised care
Standard Treatment as usual (TU) was provided during 5 years by local mental health care professionals situated nearby the domicile of patients. TU had comparable treatment targets as ST but was not provided by treatment staff specialized in early intervention in schizophrenia or related disorders. However, TU was (like ST) sustained and dedicated to prevent psychotic relapse and improve social functioning.
Interventions
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Continuity of specialized care
Continuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).
Parent groups combined with Continuity of Specialized care
Approximately fifty parent group therapy sessions will be held in a flexible way over a 60 month period. Each parent group was run by two experienced family therapists.
Discontinuity of care, non specialised care
Standard Treatment as usual (TU) was provided during 5 years by local mental health care professionals situated nearby the domicile of patients. TU had comparable treatment targets as ST but was not provided by treatment staff specialized in early intervention in schizophrenia or related disorders. However, TU was (like ST) sustained and dedicated to prevent psychotic relapse and improve social functioning.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
28 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Donald H. Linszen
Principle Investigator
Principal Investigators
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Don Linszen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Academic Medical Center University of Amsterdam
Amsterdam, North Holland, Netherlands
Countries
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References
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Linszen D, Dingemans P, Lenior M. Early intervention and a five year follow up in young adults with a short duration of untreated psychosis: ethical implications. Schizophr Res. 2001 Aug 1;51(1):55-61. doi: 10.1016/s0920-9964(01)00239-0.
Linszen D, Lenior M, De Haan L, Dingemans P, Gersons B. Early intervention, untreated psychosis and the course of early schizophrenia. Br J Psychiatry Suppl. 1998;172(33):84-9.
Linszen D, Dingemans P, Van der Does JW, Nugter A, Scholte P, Lenior R, Goldstein MJ. Treatment, expressed emotion and relapse in recent onset schizophrenic disorders. Psychol Med. 1996 Mar;26(2):333-42. doi: 10.1017/s0033291700034723.
Lenior ME, Dingemans PM, Linszen DH, de Haan L, Schene AH. Social functioning and the course of early-onset schizophrenia: five-year follow-up of a psychosocial intervention. Br J Psychiatry. 2001 Jul;179:53-8. doi: 10.1192/bjp.179.1.53.
Related Links
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The RAISE Early Treatment Program (ETP), led by John Kane, M.D., of the Feinstein Institute for Medical Research in Manhasset, NY, is conducting a similar RCT with the same population and a comparable design.
Other Identifiers
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Grant 28-1241-2
Identifier Type: -
Identifier Source: org_study_id