Schizophrenia MedDRA version: 21.1 Level: LLT Classification code 10039643 Term: Schizophrenic psychoses System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Spironolacton HEXAL
Product Name: Spironolacton HEXAL
Pharmaceutical Form: Capsule, hard
CAS Number: 52-01-7
Current Sponsor code: SPIROTREAT
Other descriptive name: SPIRONOLACTON
Concent
Sponsors
Klinikum der Universität München - AöR vertreten durch den Vorstand des Bereiches umanmedizinH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoint: Improvement of working memory in n-back after 3 weeks. ;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 ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactBeate Schossow
Muenchner Studienzentrum
Outcome results
None listed