Condition category
Mental and Behavioural Disorders
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
05/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umcg.nl/azg/nl/english/azg/

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)

ZonMw

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

  1. 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.

  2. 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.

Additional files

Editorial Notes