Schizophrenia MedDRA version: 21.1 Level: LLT Classification code 10040707 Term: Simple type schizophrenia, chronic state System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Champix
Product Name: Champix
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: VARENICLINE
CAS Number: 249296-44-4
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Klinikum der Universität München - AöR verteten durch den Vorstand des Bereiches Humanmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female (with contraception) patients with schizophrenia (ICD-10 Criteria), age 18 to 65 being diagnosed according to the “Statistical Classification of Diseases and Related Health Problems (ICD-10)“. Diagnosis will be confirmed via the MINI interview. - Antipsychotic monotherapy or a maximum combination of two antipsychotics with a maximum dosage of 1000 mg CPZ equivalents (using the minimum effective dose method) - Being no longer in the acute phase of illness defined as (PANSS Total = 75, CGI = 4). No relevant depressive symptoms (CDSS =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Lacking capacity to give informed consent or involuntary treatment - Pregnancy or lactation - Current suicidality as well as the risk to injure others - Treatment resistance or Treatment with Clozapin - Never treated schizophrenia or documented non-compliance - Lacking german language skills - Start of antidepressants or mood stabilizers during the 1-week intervention phase. Previous treatment can be continued in unaltered dosages. - Alcohol- or substance abuse during the last 6 months before inclusion into study except for Coffein and Nicotin (smoker), no narcotic drugs may be taken during the 1-week intervention phase - Detection of active substance abuse by positive D-Urin or CDT test before start of the intervention - Epileptic seizures in the anamnesis - Epileptic potentials in EEG - Proof of active substances by positve results in D-urine or CDT. - Moderate kidney insufficiency (creatinine-clearance: 30–50 ml/min) or severe kidney insufficiency (< 30 ml/min) - Known intolerance to the study medication (Vareniclin) or to tDCS - Clinically relevant interaction between clinically necessary per-medication and investigational medicinal product (to be tested by medic software - Known intolerance to the study medications or to tDCS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether the improvement of cognitive functioning in schizophrenia via the combination of varenicline and trancranial direct current stimulation is superior to the stimulation with varenicline or tDCS alone.;Secondary Objective: To evaluate whether the improvement of cognitive functioning in schizophrenia via the combination of varenicline and trancranial direct current stimulation is superior to the stimulation with varenicline or tDCS alone.;Primary end point(s): The primary efficacy endpoint will be change in working memory according to the n-back task.;Timepoint(s) of evaluation of this end point: Day 0 (V1), Day 5 (V2), Day 33 (V3), Day 61 (V4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will include several other measures of cognition (processing speed, verbal memory, and cognitive flexibility), psychopathology (Positive and Negative Syndrome Scale), depressive symptoms (Calgary Depression Scale for Schizophrenia), functioning (Global Assessment of Functioning) and disease severity (Clinical Global Impression). Physiological measures will (1) include EEG to investigate changes regional (below the stimulation electrodes) and remote electrical activity before after intervention9 and (2) motor-cortex excitability measures to investigate the impact of varenicline (steady state) on cortical excitability and plasticity.;Timepoint(s) of evaluation of this end point: Day 0 (V1), Day 5 (V2), Day 33 (V3), Day 61 (V4) PANSS and GAF Day 0 (V1), Day 33 (V3) CDSS and CGI | — |
Countries
Germany
Contacts
Public ContactDr. med. Christiane Blankenstein
Technische Universität München Fakultät für Medizin Münchner Studienzentrum
Outcome results
None listed