Schizophrenia. The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although
Conditions
Interventions
Intervention 1: Intervention group recieve an antipsychotic (equivalent 300-1000 mg/day chlorpromazine) plus N-acetylcyctein 600 mg twice a day for 12 weeks. Intervention 2: Control group recieve an
Treatment - Drugs
Placebo
Intervention group recieve an antipsychotic (equivalent 300-1000 mg/day chlorpromazine) plus N-acetylcyctein 600 mg twice a day for 12 weeks
Control group recieve an antipsychotic (equivalent 300-1000 mg/day chlorpromazine) plus placebo twice a day for 12 weeks
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion critteria: 1.Diagnosis of Schizophrenia according to DSM4-TR criteria and clinical interview by psychiatrist; 2.Age range 15-65 years; 3.Score of at least 55 in PANSS (Positive and Negative Syndrome Scale); 4.Ability to provide informed consent and cooperation with study procedures; 5. Participants needed to be currently taking an antipsychotic agent with equal dosage of 300-1000 mg cholorpromazine for 6 month prior to study; Exclusion Criteria: 1.Patients under treatment with clozapin; 2.Any sever mental disorder(major depressive disorder, psychotic symptoms, manic phase symptoms,…); 3.No follow up at least 4 weeks durig treatment; 4.Concurrent taking a mood stabilizer (e.g., lithium, valproate, carbamazepine) 5.History of substance abuse or dependence within 6months prior to study participation (except nicotine or caffeine dependence); 6.History of mental retardation (IQ less than 70); 7.Renal, hepatic, thyroid, or hematological disorder; and any sever and chronic medical disorder 8.Pregnancy or lactation; 9.Patients currently taking drugs known to prevent GSH depletion for example Selenium or Vitamin E 10. Individuals on antidepressants treatment for other indications (Tricyclic antidepressant , MAO inhibitor ,Selective serotonine reuptake inhibitor,… )for 1 month prior to randomization 11. Individuals with a prior adverse reaction to N-acetylcyctein any component of the preparation 12.Prior history of convulsion , stroke and head trauma
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of positive and negative symptom of Schizophrenia. Timepoint: Before intervention (first visit) ,the end of the fourth week (second visit),the end of the eighth week (third visit),the end of the twelfth week (fourth visit). Method of measurement: At each visit to the PANSS testing will be completed.;Severity of cognitive symptom of Schizophrenia. Timepoint: Before intervention(first visit),the end of the fourth week (second visit) , the end of the eighth week (third visit), the end of the twelfth week (fourth visit). Method of measurement: At each visit to the forward and backward Digit span test and digit symbol test and MMSE test will be completed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effect. Timepoint: Befor intervention, the end of 4, 8, 12 weeks. Method of measurement: Clinical interview and physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Sepehrmanesh MD
Kashan University of Medical Sciences
Outcome results
None listed