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IRCT2017012832236N1 IRCT 2017-02-06 Vice chancellor for research, Mazandaran University of Medical Sciences Nigella sativa effect in the treatment of residual symptoms in patients with schizophrenia Study of the efficacy and safety of Nigella sativa (black seed) as an adjuvant to antipsychotics in patients with chronic schizophrenia: A 6-week, randomized, double-blind, placebo-controlled trial 2017-02-01 anticipated 50 Complete https://irct.ir/trial/25158 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Schizophrenia. Intervention 1: Subjects in the intervention group receive an initial dose of 500 mg/day on the three fist days, which is increased to 1000 mg/day on the fourth day and continue with the same dose until the end of the study for six weeks along with their antipsychotic regimen. Intervention 2: The control group receive their antipsychotic regimen with one placebo capsule on the three fist days, which is increased to two placebo capsule/day on the fourth day and continue until the end of the study for six weeks.
public Dr Narjes Hendouei
Department of Pharmacotherapy, Faculty of Pharmacy
Sari Iran (Islamic Republic of) +98 11 3354 3081 hendoieen@yahoo.com Mazandaran University of Medical Sciences scientific Dr Narjes Hendouei
Department of Pharmacotherapy, Faculty of Pharmacy
Sari Iran (Islamic Republic of) +98 911 327 0107 hendoieen@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1- Male or female inpatients in two long-stay Psychiatric Care and Rehabilitation Centers which are Supervised by Iranian Rehabilitation Institute located in Sari in the north of Iran 2- 18–65 years at the time of screening 3- With a diagnosis of schizophrenia(paranoid, disorganized, catatonic, or undifferentiated type)or schizoaffective disorder, based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Five Edition(DSM-V)and they are suffering from the disease for more than 2 years with residual symptomatology despite antipsychotic treatment 4- All patients are on antipsychotics for at least 1 year and a stable dose for at least 2 month are included in the trial and the antipsychotics dose remain unchanged during the trial. 5- Mood stabilizers (lithium and divalproex) and antidepressants (only the selective serotonine reuptake inhibitors (SSRIs) venlafaxine, and mirtazapine) were permitted as part of antipsychotic pharmacotherapy. Dose of these drugs must be stable for at least 2 month remain unchanged during the trial. Exclusions criteria: 1- Acute relapse (As acute relapse was defined an impending decompensation based on a PANSS score of ≥4 (moderately) on the subscore items of hostility and uncooperativeness and/or a ≥20% increase in the PANSS total score. 2- Psychiatric comorbidity(primary or secondary diagnosis of bipolar I disorder, either manic or mixed episode, as defined by Diagnostic and Statistical Manual of Mental Disorders, Five Edition(DSM-V)) 3- History of substance dependence (including alcohol, but excluding nicotine) as defined by Diagnostic and Statistical Manual of Mental Disorders, Five Edition(DSM-V)and relapse within the past 6 months, or substance abuse within the 3 months preceding the trial or positive urine test for illicit drugs 4- Electroconvulsive therapy during the 6 past months 5- Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months) 6- Mental retardation 7- Pregnant or at risk of pregnancy 8- Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury 9- Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values 10- Hypersensitivity to Nigella sativa 11- Previous treatment with Nigella sativa in the past year 12- History of neuroleptic malignant syndrome 13- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions 18 years 65 years Both F20.5 Residual schizophrenia Treatment - Drugs Placebo Subjects in the intervention group receive an initial dose of 500 mg/day on the three fist days, which is increased to 1000 mg/day on the fourth day and continue with the same dose until the end of the study for six weeks along with their antipsychotic regimen The control group receive their antipsychotic regimen with one placebo capsule on the three fist days, which is increased to two placebo capsule/day on the fourth day and continue until the end of the study for six weeks Severity of psychiatric symptoms assesment. Timepoint: at baseline and weeks 3 and 6. Method of measurement: Positive and Negative Syndrome Scale (PANSS). Depressed mood assessment. Timepoint: baseline and weeks 3 and 6. Method of measurement: Calgary Depression Scale for Schizophrenia. Clinical Global Impression of Improvement (CGI-S). Timepoint: baseline and weeks 3 and 6. Method of measurement: Clinical Global Impression of Improvement (CGI-S). Clinical Global Impression of Improvement (CGI-I). Timepoint: baseline and weeks 3 and 6. Method of measurement: Clinical Global Impression of Improvement (CGI-I). Nigella sativa induced akathisia assessment. Timepoint: baseline and weeks 3 and 6. Method of measurement: Barnes Akathisia Scale. Nigella sativa induced Movement disorder assessment. Timepoint: baseline and weeks 3 and 6. Method of measurement: Simpson–Angus Scale. Nigella sativa induced Movement disorder assessment. Timepoint: baseline and weeks 3 and 6. Method of measurement: Abnormal Involuntary Movement Scale. Vice chancellor for research, Mazandaran University of Medical Sciences Approved 2016-08-19 Mazandaran University of Medical Sciences Farahabad Road,Payambare azam complex Sari Iran (Islamic Republic of)