igella sativa effect in the treatment of residual symptoms in patients with schizophrenia

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of psychiatric symptoms assesment. Timepoint: at baseline and weeks 3 and 6. Method of measurement: Positive and Negative Syndrome Scale (PANSS).

Secondary Outcome Measures

Name	Time	Method
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.