Medication strategies in first onset schizophrenia (Mesifos)

ISRCTN	ISRCTN16228411
DOI	https://doi.org/10.1186/ISRCTN16228411
Secondary identifying numbers	NTR374; DO 0945-01-001

Submission date: 19/12/2005
Registration date: 19/12/2005
Last edited: 05/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof D. Wiersma
Scientific

University Medical Center Groningen
Department of Psychiatry
Hanzeplein 1
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3613839
Email	d.wiersma@med.umcg.nl

Study information

Study design	Multicentre randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	Mesifos
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	Quality of life
Secondary outcome measures	1. Symptomatology 2. Relapse 3. Side effects 4. Social functioning 5. Burden on the family
Overall study start date	01/08/2001
Completion date	01/08/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	All
Target number of participants	131
Key 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
Key exclusion criteria	No remission or relapse within 6 months
Date of first enrolment	01/08/2001
Date of final enrolment	01/08/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Centre Groningen (UMCG) (Netherlands)
Hospital/treatment centre

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Website	http://www.umcg.nl/azg/nl/english/azg/
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Industry

Eli Lilly B.V. (Netherlands)

No information available

Service Foundation (Stichting Diensbetoon) (Netherlands)

No information available

Support Foundation (Stichting Steun) (Netherlands)

No information available

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2006		Yes	No
Results article	results	01/09/2013		Yes	No