Mitochondrial disease associated schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Reagila
Product Name: Reagila
Pharmaceutical Form: Capsule
Sponsors
Semmelweis University, STIA-POC-2020
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is able to act and is able to understand the patient information. 2. The patient signed the patient consent form prior to the screening visit. 3. Patients (men and women) are between 18 and 65 years of age. 4. The patient has been followed by the study site for at least one year and can be tracked from electronic documentation. 5. The patient meets the diagnostic criteria for both mitochondrial disease and schizophrenia at the same time: a) Patients diagnosed with mitochondrial disease: Diagnosis of mitochondrial disease is based on composite clinical criteria (MDC: mitochondrial disease criteria https://www.nature.com/articles/gim2017125#MOESM2) and histological or molecular criteria. It is a condition that in addition to the clinical criteria for mitochondrial disease (MDC> = 2), either a molecular genetic diagnosis and / or a histological diagnosis confirm the diagnosis of mitochondrial disease. b. Based on the DSM-V, the diagnosis of schizophrenia can be made and all subgroups can be included. 6. Due to his schizophrenia, the patient requires antipsychotic medication as follows: a) the patient is already receiving cariprazine and it is clinically warranted to continue it (if the patient's condition is satisfactory, we will continue to monitor it, and if the condition is not yet optimal, the dose will be further increased during observation or supplemented with medication). eg benzoidazepine treatment or supplemented with antidepressant therapy if necessary. b) the patient did not receive antipsychotic treatment immediately prior to enrollment, but is clinically warranted and there are no contraindications to cariprazine therapy c) the patient's previous antipsychotic treatment with non-cariprazine is unsatisfactory and a change in antipsychotic is clinically warranted. 7. If the patient has already taken another antipsychotic (i.e., other than cariprazine) prior to the screening visit, it may be switched if at least one antipsychotic has previously been documented to be ineffective and psychiatric symptoms are dominated by negative symptoms. Dose equivalence to antipsychotic medication should not be more than 6 mg / day equivalent to risperidone if the patient was taking 1 antipsychotic and 8 mg / day to risperidone if 2 antipsychotics were previously received (Simpson GM et al., 2006). An antipsychotic switch may occur 30 days prior to the screening visit. 8. If the patient is already taking cariprazine prior to the screening visit, the patient may be selected. The dose can be changed during the trial. 9. Antipsychotic naïve patients may also be selected if cariprazine is indicated according to the SMPC. 10. The patient may also be selected if he or she is receiving antidepressant treatment prior to selection. Antidepressant treatment is not discontinued during the study. 11. The patient is outpatient, able and willing to follow the protocol. 12. A woman of childbearing potential is willing to use a highly effective method of contraception during treatment and for another 10 weeks, as directed by the study director. 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe renal or hepatic insufficiency. Uncontrolled diabetes mellitus. Uncontrolled epilepsy. Hypersensitivity to cariprazine or additives in Reagila. Concomittant treatment with strong or moderate CYP3A4 inhibitors/inducers. Age under 18 years or over 65 years. Alcohol- or drug addiction. Pregnancy. Breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Examination of the efficacy of cariprazine on negative symptoms in schizophrenia associated with mitochondrial dysfunction during 12 weeks of treatment. ;Secondary Objective: Examination of the efficacy of cariprazine on cognitive symptoms in schizophrenia associated with mitochondrial dysfunction during 12 weeks of treatment. Examination of the efficacy of cariprazine on affective symptoms in schizophrenia associated with mitochondrial dysfunction during 12 weeks of treatment. ;Primary end point(s): Change of PANSS scale from baseline to the 12 weeks scores in mitochondrial disease associated schizophrenia under the treatment period of 12 weeks. ;Timepoint(s) of evaluation of this end point: Comparing baseline scores to score at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in Adddenbrook's cognitive scale (comparing baseline to 12 week data). Change in scores of Beck Depression Inventory (comparing baseline to 12 week data). Change in scores of Beck Anxiety Inventory (comparing baseline to 12 week data). Counting the frequency and severity of adverse events (AE/SAE. AESI: especially laboratory markers and clinical markers of worsening mitochondrial disease symptoms). Comparing baseline and 12 week transcriptomic levels. Change of Newcastle Mitochondrial Disease Scale (NMDS), lactate levels and GDF-15. Change in EQ-5D scores. ;Timepoint(s) of evaluation of this end point: baseline - 12 week | — |
Countries
Hungary
Contacts
Public Contactp.balicza@gmail.com
Semmelweis University, Institute of Genomic Medicine and Rare Disorders
Outcome results
None listed