Add-on spironolactone for the treatment of schizophrenia
- Conditions
- F20Schizophrenia
- Registration Number
- DRKS00008750
- Lead Sponsor
- Klinikum der Universität München, Campus Großhadern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
Male and female (with contraception) patients with schizophrenia (ICD-10 Criteria), no longer in acute phase of illness (PANSS Total = 75, CGI = 4), duration of illness > 6 months, guideline-based ongoing antipsychotic treatment in monotherapy or in combination treatment with maximum two antipsychotics if clinically required, stable medication for at least one week, aged 18 to 65, capacity to consent
Following a major protocol adaption, female subjects were also permitted (approved by IRB of LMU, 04.10.2016).
Pregnancy, no contraception, current suicidality as well as injuries to others, severe neurological and internistic comorbidities, known and assumed non-compliance regarding intake of medication, current antipsychotic therapy with clozapine, antipsychotic treatment with a fully renal eliminable compound (amisulprid), known clinical necessity of antipsychotic combination treatment, no new dosing of mood stabilisers or antidepressants during 3-week intervention phase. An already existing mood stabiliser therapy (excluding lithium) or antidepressant therapy (excluding renal eliminable antidepressant) can be continued in unaltered dose. Alcohol- or substance abuse during the last 6 months before inclusion into study; nicotine and coffee are excluded. Epileptic seizures in anamnesis, known intolerance of the respective study medication, current anuresis or acute kidney failure, kidney insufficiency (creatinine clearance < 30 ml/min per 1.73 m² body surface, resp. serum-creatinine > 1.8 mg/dl), known clinically relevant hyperkalaemia or hyponatraemia, known clinically relevant hypotension (RR < 100/80), simultaneous application of potassium-sparing diuretics, ACE inhibitors or AT-II antagonists, NSAR, thiazide-diuretics, carbenoxolon, digoxin, neomycin, lithium. Missing capacity for consent or hospitalisation of patients against their will, insufficient knowledge of the German language, state of treatment resistance or never treated schizophrenia.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of working memory in n-back after 3 weeks. n-Back will be assessed using a computer-based test with the 0, 1 and 2 back condition. The primary outcome will be measured after three weeks.
- Secondary Outcome Measures
Name Time Method Improvement of other neurocognitive functions after 3 and 12 weeks (verbal memory, working speed), changes in psychopathology of PANSS (Positive and Negative Syndrome Scale) and CDSS (Calgary Depression Scale for Schizophrenia), changes in CGI (Clinical Global Impression) and GAF (Global Assessment of Functioning), occurrence of single side effects, changes of cortical inhibition, changes in ERBB4 metabolic pathway.