Patients with Predominant Negative Symptoms of Schizophrenia MedDRA version: 16.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Cariprazine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Cariprazine hydrochloride
CAS Number: 839712-12-8
Current Sponsor code: RGH-188 HCl
Other descriptive name: CARIPRAZIN
Sponsors
Gedeon Richter Plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •The patient is able to read and understand the patient information sheet. •Prior to any screening procedures, the patient must have signed the informed consent form. •Men and women, aged between 18-65 years (extremes included), suffering from schizophrenia (DSM-IV-TR diagnosis, all subtypes allowed). •The onset of schizophrenia has been known for at least 2 years prior to the Screening Visit. •The patient should be known by the investigator, either directly or via another psychiatrist from the site or via a referring psychiatrist. Reliable source data including detailed history of the patient’s diagnosis of schizophrenia for at least a period of one year prior to the Screening Visit must be available to the investigator. •Predominant negative symptoms present for at least 6 months at the Screening Visit, based on the medical records and the judgment of the investigator. •A Positive and Negative Syndrome Scale (PANSS) factor score for negative symptoms > or = 24. •A score of > or = 4 on a minimum 2 of the 3 PANSS items oFlat affect (N1 – Blunted affect), oPoverty of speech (N6 – Lack of spontaneity and flow of conversation), oAvolition (N4 – Passive/apathetic social withdrawal). •Female patients of non-childbearing potential or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods. •If the patients are treated with antipsychotic medications at the Screening Visit, they must receive one or a maximum of 2 different antipsychotic(s). Dose equivalence of the antipsychotic medications must not be higher than 6 mg risperidone equivalent daily if the patient is treated with 1 antipsychotic and 8 mg equivalent risperidone daily if the patient is treated with 2 antipsychotics (Simpson GM et al., 2006). No change in their antipsychotic medication(s) within 30 days before the Screening Visit is allowed. Dosage may be changed, but not the medication(s). 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 411 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: •Current DSM-IV-TR–based primary diagnosis of mental retardation or an axis I disorder, other than schizophrenia. •Other psychiatric, neurological, or behavioural disorders that may interfere with the conduct or interpretation of the study. •The condition of the patient is unstable: oHospital admission for, or history of acute exacerbation of schizophrenia within 6 months prior to the Screening Visit, based on the medical records, or during the 4-week Prospective Lead-in Period. oMajor increase in psychiatric care or imprisonment within the last 6 months prior to the Screening Visit, based on the medical record, or during the 4-week Prospective Lead-in Period. oA total PANSS positive factor score >19. oin order to avoid pseudospecificity a score of =4 on more than 2 of the following PANSS items: P1 – delusions, P3 – hallucinatory behaviour, P5 – grandiosity, P6 – suspiciousness, G9 – unusual thought content. •Substance abuse or dependence (other than nicotine or caffeine) within the prior 12 months. •Presence of moderate to severe depressive symptoms, defined by the Calgary Depression Scale for Schizophrenia (CDSS) total score >6. •The patient has clinically relevant parkinsonian symptoms (EPS) as judged by the investigator and/or clinically significant parkinsonian symptoms as evaluated by the sum of the first 8 items on the SAS > 3. •Treatment with antidepressant medications within 3 months prior to the screening visit. •Being at significant risk of suicide defined as, in the 12 months prior to Screening, significant risk of suicide according to the investigator judgment, based upon all available source of information including those collected in the C-SSRS; and/or within the 5 years prior to Screening, more than one life-threatening suicide attempt. •Known or suspected cluster B personality disorders (borderline, antisocial, histrionic and narcissi personality disorders). •Violent behaviour in the 12 months prior to Screening, according to the investigator’s judgment and/or on PSP scale “Domain d. – Disturbing and agressive behaviors” scored as “Marked”, “Severe” or “Very severe” at Screening Visit. •Treatment with risperidone within 6 weeks of the Screening Visit. •History of non-response of a psychotic episode to an adequate trial of risperidone treatment. •Single episode of schizophrenia without residual symptoms (DSM-IV TR criteria). •Treatment with clozapine in the 12 months prior to Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, safety and tolerability of cariprazine for the treatment of patients with schizophrenia having predominant negative symptoms.;Secondary Objective: No secondary objectives;Primary end point(s): Change from baseline (CFB) to endpoint (Week 26) in the PANSS factor score for negative symptoms;Timepoint(s) of evaluation of this end point: week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CFB to endpoint (Week 26) in Personal and Social Performance (PSP) score CFB in PANSS negative subscale score at Week 26 CFB on CGI-S at Week 26 CFB in PANSS total score at Week 26 CFB in PANSS general psychopathology scale at Week 26 CGI-I score at Week 26 Responder rates based on number of patients who achieve a decrease of at least 20% in baseline PANSS factor score for negative symptoms ;Timepoint(s) of evaluation of this end point: week 26 | — |
Countries
Bulgaria, Croatia, Czech Republic, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine
Contacts
Public ContactHerta Pálfi Goóts
Gedeon Richter Plc
Outcome results
None listed