| Abstrakt: |
Background: When achieving remission after a first psychotic episode using antipsychotic medication, international guidelines generally recommend continuation of use for >1 year. However, patients often have a strong wish to stop earlier due to side-effects, affecting everyday functioning. Recently, guidelines have been questioned as one Dutch study found that more patients achieved long-term functional remission after early discontinuation. Yet, this finding has not yet been replicated. Psychiatrists, patients and family are unsure which regime to follow: to continue or not to continue? Methods: In total 512 participants will be included who achieved remission after first-episode psychosis and use antipsychotic medication. Recruitment takes place at 24 Dutch sites. HAMLETT is a multicenter pragmatic single- blind randomized controlled trial with two conditions (1:1): maintenance treatment versus discontinuation/dose reduction of antipsychotic medication. Main research question: Is long-term general functioning better if patients reduce/discontinue antipsychotic medication at an early stage (3–6 months after remission of their first psychotic episode), than when they continue medication >1 year? General functioning is measured in two ways: with the WHO-DAS interview and with Ecological Momentary Assessments (EMA). EMA is a structured diary method in which individuals are asked in daily life to report on their current thoughts, feelings and symptoms, as well as the context (e.g. location, company, activity) and the appraisal of the context (e.g. stress). Diaries are completed via a smartphone diary app maximally 10 times daily at semi-random moments, over eight consecutive days. Momentary positive/negative affect, self-esteem, subjective well-being, paranoia, hallucinations, sleep, and frequency, type and appraisal of social company and activities are assessed on a 1–7 scale. At baseline and after 6 months, 1, 2, 3 and 4 years follow-up, patients of both arms will perform EMA. This results in an intensive time series of psychopathology, subjective well-being and social functioning in relation to antipsychotic medication and a range of contextual influences. Results: The study is active and currently recruiting patients (since September 2017), At present 194 patients have been included, 20% participated in EMA measurements. Results of the interim analysis and preliminary of EMA data will be presented. Discussion: The HAMLETT study investigates the effects of maintenance treatment versus discontinuation/dose reduction of antipsychotic medication after remission of first episode psychosis on personal and social functioning, psychotic symptom severity, health-related quality of life and cognitive functioning. The HAMLETT study will offer evidence to guide patients and clinicians when evaluating optimal treatment duration for psychotic disorders. Using different types of outcome measures will provide a more in-depth analysis of effects of continuation/ discontinuation on functioning. [ABSTRACT FROM AUTHOR] |
