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Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial

5 september 2013 uppdaterad av: Donald H. Linszen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Relapse Prevention in First Episode of Schizophrenia and Related Psychotic Disorders: a 5 Year Randomized Controlled Trial

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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Nederländerna
    • N Holland
      • Amsterdam, N Holland, Nederländerna, 1105BC
        • Academic Medical Center University of Amsterdam

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år till 28 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Continuity of specialized care
Continuity of specialized inpatient and outpatient care (relapse prevention)
Beteende: 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).
Andra namn:
  • Förebyggande av återfall
  • Specialized treatment
  • Maintenance antipsychotic medication
Experimentell: Continuity of specialized care and parent groups
Continuity of specialized care combined with Parent groups
Beteende: 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).
Andra namn:
  • Förebyggande av återfall
  • Specialized treatment
  • Maintenance antipsychotic medication
Beteende: 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.
Andra namn:
  • 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.
Aktiv komparator: Treatment as usual
Discontinuity of care, relapse prevention as usual
Beteende: 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.
Andra namn:
  • Standard relapse prevention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Psychotic relapse
Tidsram: 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.
at year 1, year 3 and year 5

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Social functioning
Tidsram: 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.
at year 1, year 3 and year 5

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Samarbetspartners

ZonMw: The Netherlands Organisation for Health Research and Development

Utredare

  • Huvudutredare: Don Linszen, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 1997

Primärt slutförande (Faktisk)

1 februari 2007

Avslutad studie (Förväntat)

1 februari 2016

Studieregistreringsdatum

Först inskickad

23 augusti 2013

Först inskickad som uppfyllde QC-kriterierna

5 september 2013

Första postat (Uppskatta)

6 september 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 september 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 september 2013

Senast verifierad

1 september 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Grant 28-1241-2

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