Contact information
Type
Scientific
Primary contact
Prof D. Wiersma
ORCID ID
Contact details
University Medical Center Groningen
Department of Psychiatry
Hanzeplein 1
Groningen
9700 RB
Netherlands
+31 (0)50 3613839
d.wiersma@med.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR374; DO 0945-01-001
Study information
Scientific title
Acronym
Mesifos
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?
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Non affective psychosis, schizophrenia
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Quality of life
Secondary outcome measures
1. Symptomatology
2. Relapse
3. Side effects
4. Social functioning
5. Burden on the family
Overall trial start date
01/08/2001
Overall trial end date
01/08/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
131
Participant exclusion criteria
No remission or relapse within 6 months
Recruitment start date
01/08/2001
Recruitment end date
01/08/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Centre Groningen (UMCG) (Netherlands)
Sponsor details
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Eli Lilly B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Service Foundation (Stichting Diensbetoon) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Support Foundation (Stichting Steun) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/16638078
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23824214
Publication citations
-
Results
Wunderink A, Nienhuis FJ, Sytema S, Wiersma D, Treatment delay and response rate in first episode psychosis., Acta Psychiatr Scand, 2006, 113, 4, 332-339, doi: 10.1111/j.1600-0447.2005.00685.x.
-
Results
Wunderink L, Nieboer RM, Wiersma D, Sytema S, Nienhuis FJ, Recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy: long-term follow-up of a 2-year randomized clinical trial., JAMA Psychiatry, 2013, 70, 9, 913-920, doi: 10.1001/jamapsychiatry.2013.19.