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Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial

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ClinicalTrials.gov Identifier: NCT01936220
Recruitment Status : Unknown
Verified September 2013 by Donald H. Linszen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Enrolling by invitation
First Posted : September 6, 2013
Last Update Posted : September 6, 2013
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Donald H. Linszen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

Objective: to evaluate the effectiveness of specialised and sustained intervention with or without parent groups during the initial phase of schizophrenia or related disorders on relapse prevention

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Continuity of specialized care Behavioral: Parent groups combined with Continuity of Specialized care Behavioral: Discontinuity of care, non specialised care Not Applicable

Detailed Description:

Evidence for optimal duration and necessary ingredients of early and sustained specialized treatment from first episode psychosis till the end of the initial phase schizophrenia is still insufficient. Randomized trials with a treatment duration of six months to two years with favorable symptomatic and psychosocial results disappeared at five year follow-up. Other studies suggest that specialized treatment should last 5 years in order to be able to prevent instead of only delaying clinical and psychosocial deteriorating.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relapse Prevention in First Episode of Schizophrenia and Related Psychotic Disorders: a 5 Year Randomized Controlled Trial
Study Start Date : September 1997
Actual Primary Completion Date : February 2007
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuity of specialized care
Continuity of specialized inpatient and outpatient care (relapse prevention)
Behavioral: 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).
Other Names:
  • Relapse prevention
  • Specialized treatment
  • Maintenance antipsychotic medication

Experimental: Continuity of specialized care and parent groups
Continuity of specialized care combined with Parent groups
Behavioral: 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).
Other Names:
  • Relapse prevention
  • Specialized treatment
  • Maintenance antipsychotic medication

Behavioral: 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.
Other Names:
  • Family management as developed by Goldstein, Anderson, Falloon, Schooler and collaborators
  • Adaptation developed for parents of first psychotic episode patients as described in an earlier study of our group.

Active Comparator: Treatment as usual
Discontinuity of care, relapse prevention as usual
Behavioral: 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 Name: Standard relapse prevention




Primary Outcome Measures :
  1. Change in Psychotic relapse [ Time Frame: at year 1, year 3 and year 5 ]

    Participants will be followed for the duration of the 5 year outpatient treatment of the trial. During the trial the timing and number of psychotic relapses of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial.

    Trained interviewers not involved in clinical treatment of patients will elicit with the LCS detailed information of symptoms, signs and treatment from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in symptomatology since the last interview. All details will be fitted in a schedule with 6 months intervals.



Secondary Outcome Measures :
  1. Change in Social functioning [ Time Frame: at year 1, year 3 and year 5 ]

    During the duration of the 5 year outpatient treatment of the trial social functioning of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial.

    Detailed information of social functioning in work, study, school and relations will be elicited from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in functioning since the last interview.All details will be fitted in a schedule with 6 months.




Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were eligible for the study if they: 1) met DSM-IV-Revised criteria for schizophrenia or related disorders, 2) were suffering from a first psychotic episode and 3) were living in contact with parent(s) or other relatives.

Exclusion Criteria:

  • Patients with drug-related psychoses were not included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936220


Locations
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Netherlands
Academic Medical Center University of Amsterdam
Amsterdam, N Holland, Netherlands, 1105BC
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Don Linszen, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications:
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Responsible Party: Donald H. Linszen, Principle Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01936220     History of Changes
Other Study ID Numbers: Grant 28-1241-2
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013

Keywords provided by Donald H. Linszen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Schizophrenia
First-psychotic episode
Initial phase
Relapse prevention
Specialized treatment
Parent groups
Social functioning

Additional relevant MeSH terms:
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Schizophrenia
Recurrence
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes