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
Scientific
University Medical Center Groningen
Department of Psychiatry
Hanzeplein 1
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3613839 |
|---|---|
| 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 | Both |
| 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
9700 RB
Netherlands
Sponsor information
University Medical Centre Groningen (UMCG) (Netherlands)
Hospital/treatment centre
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
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 |
