PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES MedDRA version: 14.1 Level: PT Classification code 10061920 Term: Psychotic disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: ACETILCISTEINA FARMASIERRA 600 mg
Product Name: N-acetylcysteine
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed INN: ACETYLCYSTEINE
CAS Number: 616-91-1
Concentr
Sponsors
Fundación para la Investigación Biomédica Hospital Gregorio Marañón
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Age between 12 and 18 years; 2 Presence of at least one psychotic symptom of onset before 18 years of age, with a diagnosis of psychotic disorder criteria DSM-IV (F20 or F30), evaluated through the K-SADS (Kiddie Schedule for Affective Disorders and Schizophrenia); 3 Previous exposure to antipsychotics ? 30 days; 4 Informed consent of the patient and of the guardian or legal representative. Are the trial subjects under 18? yes Number of subjects for this age range: 70 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Co-morbidity with other disorders of axis I, included abuse or dependence on toxic (use is accepted); 2. Presence of organic diseases of the central nervous system (CNS) or a history of head trauma with loss of consciousness; 3. Mental retardation; 4. Pervasive development disorders; 5. Clinically relevant renal, hepatic or haematological findings in the analysis of screening; 6. Active medical conditions (e.g. seizures not controlled); 7 Patients with ulcus gastroduodenal, asthmatic or with severe respiratory failure; 8 Persons who have previously submitted adverse effects to the NAC or any of the components of the preparation; 9 Pregnancy, breastfeeding or risk of pregnancy (contraceptive measures an intrauterine device, oral contraceptives and barrier methods are considered); 10 People who are in treatment with other agents antioxidants or precursors of GSH, except if treatment has been abandoned at least 3 weeks; 11 Patients who are participating or have participated in another clinical trial during the previous 30 days; 12 Patients unable to meet the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the variations in volume of gray matter in patients with early onset psychotic episodes after 48 weeks of treatment with NAC or placebo;Secondary Objective: -To assess the changes in the concentrations of brain GSH in patients with early onset psychotic episodes before and after treatment -To assess the changes in oxidative metabolic status of patients in patients with early onset psychotic episodes before and after treatment - To Assess variations in volume of white matter in patients in patients with early onset psychotic episodes after treatment - To relate the loss of volume of gray matter in patients with early onset psychotic episodes with markers of oxidative stress. - To study markers of central and peripheral oxidative stress as possible biomarkers that can predict response to NAC. - To compare the changes in clinical and psychopathology scales (CGI, PANSS, YMRS, HAM-D) - To compare the changes in the psychosocial functioning (C-GAS, WHO-DAS) after treatment - To compare the required antipsychotic doses - To compare the frequency and intensity of adverse effects associated with neuroleptic treatment (AIMS, BARS);Primary end point(s): Volumetric changes in frontal gray matter (right over left) measured by nuclear magnetic resonance (NMR) after 48 weeks of adjuvant treatment with NAC or placebo.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in cerebral GSH concentrations measured by spectroscopy (MRS) after 48 weeks of treatment with NAC or placebo. 2 Volumetric changes in brain white matter measured by diffusion (DTI) after 48 weeks of treatment with NAC or placebo. 3. Changes in the values of markers of oxidative metabolism after 48 weeks of adjuvant treatment with NAC and placebo in a year. 4. Changes in the score in clinical and psychopathology scales (CGI, PANSS, YMRS, HAM-D) and psychosocial functioning (C-GAS, WHO-DAS) after 48 weeks of adjuvant treatment with NAC or placebo. 5 Doses of antipsychotic and extrapyramidal side effects of antipsychotic treatment (AIMS, BARS) after 48 weeks of treatment with NAC or placebo;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
Spain
Contacts
Public ContactGoretti Moron
Fundación para la Investigación Biomédica Hospital Gregorio Marañón
Outcome results
None listed