Medication strategies in first onset schizophrenia (Mesifos).|
|- candidate number||1584|
|- NTR Number||NTR374|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||DO 0945-01-001 |
|- Public Title||Medication strategies in first onset schizophrenia (Mesifos).|
|- Scientific Title||Medication strategies in first onset schizophrenia (Mesifos).|
|- hypothesis||Overall research question: |
Is there a difference in quality of life between patients with a first psychotic episode, treated with targeted and maintenance treatment?
1. Do both treatment strategies differ with respect to quality of life, subjectively as well as objectively, regarding work, daily activities, housing, social network, satisfaction and wellbeing, including (para)suicide, aggressive behaviors towards others, contacts with police, days in jail), and to social role functioning?
2. Do both treatment strategies differ with respect to the course of the illness (relapse, quality of remission), side-effects of medication (dyskinesia, EPS, subjective well-being), and dependence on care facilities (including involuntary admission)?
3. Does the psychosocially oriented treatment lead to better compliance and earlier recognition of prodromal signs with the possibility of prevention of full blown psychosis by targeted pharmacological treatment?
4. Can we identify predictors of successful drug withdrawal/discontinuation?
5. To what extent are these treatment strategies acceptable to this patient population?
6. To what extent do early drop out and refusal make a difference with respect to mental health care consumption and social outcome?
7. Do direct medical costs differ between the two strategies?
8. Is there a difference regarding indirect costs and burden on the family?
|- Healt Condition(s) or Problem(s) studied||Schizophrenia, Non affective psychosis |
|- Inclusion criteria||1. Suffering from a first episode of psychosis; |
2. Being 18- 45 years of age;
3. Being treatment na´ve;
4. Responding to medication (remission of positive symptoms) within 6 months and remaining stable for another 6 months.
|- Exclusion criteria||No remission or relapse within 6 months.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2001|
|- planned closingdate||1-aug-2005|
|- Target number of participants||131|
|- Interventions||Maintenance treatment was carried out according to the guidelines of the APA. This entailed the preferred use of second-generation antipsychotics in low dose.
In targeted treatment the dose was gradually tapered in one or two months and discontinued, if possible. Tapering was allowed to be more gradual, subject to symptom levels and individual preferences of patients. If early warning signs of relapse emerged or positive symptoms recurred, clinicians were to reinstate or increase the dose of antipsychotic medication, not only in targeted, but also in maintenance treatment. If feasible and considered safe, in targeted treatment discontinuation was tried again. |
|- Primary outcome||Quality of life.|
|- Secondary outcome||1. Symptomatology; |
3. Side effects;
4. Social functioning;
5. Burden on the family.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. D. Wiersma|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A. Wunderink|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Eli Lilly Nederland B.V., Stichting Steun, Stichting Diensbetoon|
|- Publications||Acta Psychiatr Scand. 2006 Apr;113(4):332-9.|
|- Brief summary||Context:|
Treatment guidelines for first episode psychosis recommend maintenance treatment for at least one year (APA) or even two years in The Netherlands. These are based on limited evidence since no prospective study yet compared targeted and maintenance treatment in remitted first episode psychosis.
To evaluate differential effects of targeted and maintenance treatment strategies in remitted first episode patients.
After six months of stable remission of positive symptoms patients were randomly and openly assigned to one of the two treatment strategies. Follow-up was eighteen months. Ratings were single-blinded.
Seven mental health care organizations with a catchment area of 3.1 million inhabitants, coordinated by Department of Psychiatry of the University Medical Center Groningen in the Netherlands.
Epidemiologically representative cohort of 131 first episode patients, aged 18 to 45 years, with a diagnosis of schizophrenia or related psychotic disorder experiencing six months of stable remission.
Maintenance treatment strategy carried out according to APA-guidelines using mostly low dose atypical antipsychotics. Targeted treatment strategy carried out by gradually tapering dose and discontinuation.
Main outcome measures:
Relapse, psychopathology, side effects, social and vocational functioning, hospitalization and quality of life.
Twice as many relapses occurred in targeted treatment (43% vs. 21%, P = 0.007) but neither positive or negative symptoms, side effects, social functioning, nor quality of life differed between strategies during follow-up. Patients in targeted treatment also did not spend more days in hospital while they tended to hold a regular job more often at follow-up (35% vs. 17%, P = .06).
Targeted treatment seems to be a feasible alternative to maintenance treatment in stably remitted first episode patients. Though relapses were more frequent in targeted treatment, this had no impact on hospitalization or other functional outcome, while medication use was significantly less and vocational functioning tended to be better.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 4-sep-2008|
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