Add-on spironolactone for the treatment of schizophrenia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Essential inclusion Criteria:
Male and female patients with schizophrenia (ICD-10 Criteria), no longer in acute phase of illness (PANSS Total = 75, CGI = 4), duration of illness > 6 months, age between 18 and 65 years
Have need for a combination treatment with a maximum of 2 antipsychotics. Excluded antipsychotics can be found under 4.3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Essential exclusion Criteria:
Female Patients: Pregnancy, no medically-approved methods of 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 exclusively a renal eliminable compound (amisulprid), planned 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 (only for additional examination TMS with separate Informed Consent Form), 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.
Known clinical need for antipsychotic combination treatment with more than two antipsychotics.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary endpoint: Improvement of working memory in n-back after 3 weeks. <br>;Secondary Objective: Secondary endpoints: Improvement of other neurocognitive functions after 3 and 12 weeks (verbal memory, working speed), changes in psychopathology of PANSS and CDSS, changes in CGI and GAF, occurrence of single side effects, changes of cortical inhibition, changes in ERBB4 metabolic pathway<br>;Primary end point(s): Primary endpoint: Improvement of working memory in n-back (2-back hits) after 3 weeks. ;Timepoint(s) of evaluation of this end point: 3 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints: Improvement of other neurocognitive functions after 3 and 12 weeks (further parameters of working memory) verbal memory, working speed), changes in psychopathology of PANSS and CDSS, changes in CGI and GAF, occurrence of single side effects, changes of cortical inhibition, changes in ERBB4 metabolic pathway. Comparison of both verum arms vs. placebo;Timepoint(s) of evaluation of this end point: after 3 and 12 weeks

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