Medication strategies in first onset schizophrenia (Mesifos)
| ISRCTN | ISRCTN16228411 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16228411 |
| Protocol serial number | NTR374; DO 0945-01-001 |
| Sponsor | University Medical Centre Groningen (UMCG) (Netherlands) |
| Funders | Eli Lilly B.V. (Netherlands), Service Foundation (Stichting Diensbetoon) (Netherlands), Support Foundation (Stichting Steun) (Netherlands), Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Quality of life |
| Key secondary outcome measure(s) |
1. Symptomatology |
| 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 sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
