TAILOR - a randomized clinical trial
The aim of the study is to investigate the effect of closely monitored discontinuation versus maintenance therapy with antipsychotic medication in patients with newly diagnosed schizophrenia and schizophreniform psychosis and with minimum three months remission of psychotic symptoms. It is evaluated whether it is possible to reduce dosage or even discontinue treatment with antipsychotic medication without experiencing relapse of psychotic symptoms. Furthermore the effect will be measured regarding negative symptoms, dosage of antipsychotic medication, cognition, client satisfaction, sideeffects of antipsychotic medication, psychosocial functioning, recovery, use of psychoactive substances and alcohol, sexual functioning, service user support and quality of life.
The trial will contribute with knowledge to evidence based recommendations about duration of treatment with antipsychotic medication and the possibilities of dose reduction in patients with newly diagnosed schizophrenia or schizophreniform psychosis and in the long run contribute to more individualized recommendations.
In the trial 250 trial subjects will be recruited and half of them will be offered closely monitored tapered discontinuation. They will get a tailored instruction for tapering off the specific medicinal product and dose reductions. The intervention will last one year and hereafter the effects will be measured. Furthermore there will be follow-ups after two and five years.
The remaining 125 trial subjects will continue maintenance treatment with antipsychotic medication with the same medicinal product or active substance and dosage which they entered the study with.
Schizophrenia and schizophreniform psychosis is related to big costs for the individual, the family and society. The symptoms of schizophrenia are often psychotic symptoms (hallucinations and delusions), negative symptoms (eg. poverty of speech, blunted affect, lack of motivation) and cognitive dysfunction (eg. reduced verbal memory and social cognition impairment). The psychotic symptoms affects thought processing, judgement, behavior and emotions in ways which can be both frightening and disabling. Also the negative symptoms and cognitive impairment have a crucial influence on function and life quality.
Antipsychotic medication is effective for psychotic symptoms in schizophrenia and schizophreniform psychosis but has limited effects for negative symptoms and unclear effect on cognitive function.
There is no doubt that antipsychotic medication reduces the risk of relapse after remission of psychotic symptoms - at least in the short term. This is the rationale for nationally and internationally recommending long term maintenance treatment with antipsychotic medication in schizophrenia. However there are considerable side effects of all antipsychotics. Some of these are potentially a health hazard and after discontinuation some will cease while it is unknown with other side effects. Long term studies show that more than half of patients with first-episode schizophrenia have no psychotic symptoms after 10 years and half of them have not taken antipsychotic medication the past two years. This shows that a big part of patients with schizophrenia on long term do not need antipsychotic medication.
1. To investigate the frequency of subjects who are not in treatment with antipsychotic medication and has remission of psychotic symptoms in the discontinuation group compared with the maintenance therapy group measured at one and two year follow up.
1. To investigate the following in the discontinuation group compared with the discontinuation group at one, two and five year follow up
2. The frequency of psychotic relapse
3. The frequency of sideeffects of antipsychotic medication
4. Social functioning
5. Cognitive functioning
6. The frequency of clinical recovery
7. Alcohol and psychoactive substance use
Description of the cohort
Patients are included from Region Hovedstaden and Region Midtjylland and the total number of expected included participants is 250.
- Age of minimum 18 years
- First treatment in the OPUS treatment center with the ICD 10 diagnosis F20 (except F20.6) or F22 confirmed with the diagnostic interview SCAN (Schedule for Clinical Assessment in Neuropsychiatry)
- Minimum three months remission of psychotic symptoms (based on assessment with SAPS-Schedule for Assessment of Positive Symptoms in Schizophrenia) and within the first 11 months of treatment in the OPUS center.
- In treatment with antipsychotic medication (daily or depot)
- Fluent in Danish
- Informed consent
- Principal exclusion criteria
- Patients in forensic psychiatry
- Treatment with clozapine
- Pregnancy or breastfeeding
- Previous admission to psychiatric hospital due to psychotic relapse while treated with antipsychotic medication or tapering of antipsychotic medication
Data and biological material
Data will be collected at baseline, 1 year, 2 year and 5 year followup.
The data is from interview, questionnaires, registers and blood samples and a physical examination. There will be data on positive and negative symptoms (SAPS and SANS), cognition (BACS), social functioning (GSDS, GAF, PSP), recovery, quality of life (WHO-5), client satisfaction (CSQ), side-effects of antipsychotic medication (UKU), sexuality (CFSQ) and substance use and alcohol (Timeline followback). Register data will be from the cpr-register, Dødsårsagsregistret, Landspatientregistret, Danmarks statistik, DREAM databasen, Lægemiddelstatistikregistret, Register over Tvang i Psykiatrien og det Danske Psykiatriske Centrale Forskningsregister.
Blood samples are collected at baseline, 1-, 2- and 5-year follow-up and analyzed immediately. There will be no biobank.
Collaborating researchers and departments
Psychiatric Centre Copenhagen
- Professor and Consultant Annamaria Giraldi, PhD
- Department of Clinical Biochemistry
Aarhus University Hospital
Institute of Clinical Medicine, Aarhus University