Welcome
Support Centre
30 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Medication strategies in first onset schizophrenia (Mesifos)
ISRCTN ISRCTN16228411
DOI 10.1186/ISRCTN16228411
ClinicalTrials.gov identifier
EudraCT number
Public title Medication strategies in first onset schizophrenia (Mesifos)
Scientific title
Acronym Mesifos
Serial number at source NTR374; DO 0945-01-001
Study 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?
Detailed questions:
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?
Lay summary Not provided at time of registration
Ethics approval Received from local medical ethics committee
Study design Multicentre randomised open label active controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Non affective psychosis, schizophrenia
Participants - inclusion criteria 1. Suffering from a first episode of psychosis
2. 18-45 years of age
3. Treatment naïve
4. Responding to medication (remission of positive symptoms) within 6 months and remaining stable for another 6 months
Participants - exclusion criteria No remission or relapse within 6 months
Anticipated start date 01/08/2001
Anticipated end date 01/08/2005
Status of trial Completed
Patient information material
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 measure(s) Quality of life
Secondary outcome measure(s) 1. Symptomatology
2. Relapse
3. Side effects
4. Social functioning
5. Burden on the family
Sources of funding 1. Eli Lilly B.V. (Netherlands)
2. Service Foundation (Stichting Diensbetoon) (Netherlands)
3. Support Foundation (Stichting Steun) (Netherlands)
4. Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Trial website
Publications 1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/16638078
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23824214
Contact name Prof  D.  Wiersma
  Address University Medical Center Groningen
Department of Psychiatry
Hanzeplein 1
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Tel +31 (0)50 3613839
  Email d.wiersma@med.umcg.nl
Sponsor University Medical Centre Groningen (UMCG) (Netherlands)
  Address Hanzeplein 1
  City/town Groningen
  Zip/Postcode 9713 GZ
  Country Netherlands
  Sponsor website: http://www.umcg.nl/azg/nl/english/azg/
Date applied 19/12/2005
Last edited 05/07/2013
Date ISRCTN assigned 19/12/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.