EFFECT OF ADJUVANT TREATMENT WITH N - ACETYLCYSTEINE DURING 48 WEEKS ON THE LOSS OF GREY SUBSTANCE AND OXIDATIVE METABOLISM IN PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES: BLIND, PLACEBO-CONTROLLED, RANDOMIZED CLINICAL TRIA

• Conditions: PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES; MedDRA version: 14.1Level: PTClassification code 10061920Term: Psychotic disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-005435-87-ES
• Lead Sponsor: Fundación para la Investigación Biomédica Hospital Gregorio Marañón

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-20
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified