psychosis/schizophrenia
Conditions
Interventions
Intervention: Patients are randomised 1:1 to
1. Treatment as usual: continuation of antipsychotic medication (original dose
+/- 25% or other antipsychotic drug in similar dose range) until at least 1
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. The participant has had a first episode of psychosis and uses antipsychotic medication. Eligible patients who have already discontinued their medication can participate without randomization. 2. Psychotic symptoms are in remission for 3-6 months. with an antipsychotic. 3. Age 16-60 years. 4. The participant understands the study and is able to provide written informed consent. 5. HAMLETT is the only medical-scientific medication study in which the patient participates (during the first four year of participation) 6. Sufficient command of the Dutch language.
Exclusion criteria
Exclusion criteria: 1. Dangerous or harmful behaviour (i.e. behaviour where there was a risk of severe physical injury, or there was actual physical injury inflicted, to self or others) occurred during the psychosis. 2. Coercive treatment (based on a judicial ruling).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: Primary outcome measure is based on what patients and their relatives deemed most important, as assessed in a survey conducted by Anoiksis. This was long-term social recovery and is best quantified with the World Health Organization*s Disability Assessment Schedule (WHODAS-II). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Subjective reactions to the use of mental health medications (Subjective Wellbeing on Neuroleptics Scale, SWN; Naber, 1995; Subjective Reaction on Antipsychotics, SRA; Wolters et al., 2003) • Physical health (body mass index (BMI) and somatic comorbidity including metabolic syndrome) • Quality of life assessed with the EuroQoL (EQ-5D-5L; Sonntag et al., 2015) • The economic costs of health care uptake and productivity losses with the TiC-P (Hakkaart van Roijen, et al., 2002) • Symptom severity as assessed with the Positive and Negative Symptom Scale (PANSS; Kay et al., 1987) • The Premorbid Adjustment Scale (PAS;Cannon-Spoort et al., 1982 ) is a rating scale about five domains of functioning: sociability, peer relationships, scholastic performance, adaptation to school and social-sexual aspects. It covers two life periods: up to 12 and 12 to 16. • Recovery Assessment Scale (RAS; Giffort et al.1995 ) • Multidimensional Scale of Perceived Social Support (MSPSS;Zimet et al.,1988 ) • Aggression and self-harming behaviour (developed by the department of psychiatry UMCU) • Self-esteem with (SERS-S; Lecomte et al., 2006) • Internalised stigma of mental illness (ISMI; Ritsher et al., 2003) • Psychosis attachment measure (PAM; Berry et al., 2008) • Cognitive functioning as assessed with the Brief Assessment of Cognition in Schizophrenia (BACS; Keefe et al., 2004) and the Stroop task (Stroop, 1935). • Movement disorders as assessed with the St. Hans rating scale (Gerlach et al., 1993) and Barnes Akathisia rating Scale (BARS; Barnes, 1989) • Clinical variables, including number and duration of psychotic relapses; number and duration of psychiatric admissions; total time spent with the treatment team • Cigarette, alcohol and drug abuse (as assessed with the alcohol and drug section of the Comprehensive Assessment of Schizophrenia: CASH; Andreasen e.a., 1992 and the WHO assist (Humeniuk et al., 2010) . MINI Screener is a selfreport questionair | — |
Countries
Netherlands
Outcome results
None listed