Schizophrenia with residual symptoms. Residual schizophrenia
Conditions
Interventions
Intervention 1: Intervention group: Previous prescription antipsychotic treatment + ondosterone drug at a dose of 4 mg per day for the first week and 8 mg per day (in two divided doses) for the second
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 18-65 years old male patients Patients with a diagnosis of schizophrenia based on DSM-5 criteria for at least two years who should still be symptomatic despite treatment with antipsychotic medications. Patients should be treated with antipsychotic medications for at least one year, and the type and dose of their antipsychotic medications should remain constant for the last three months. If they are taking medications such as mood stabilizers or antidepressants with their antipsychotic treatment regimen, their type and dose will remain the same for three months before the start of the study and during the study. If they are taking anticholinergic drugs (which include bipyridine or trihexylphenidyl) in combination with their antipsychotic treatment regimen for treatment or prevention the Movement side effects of antipsychotics, the type and dose of them remain stable for three months before the start of and during the study.
Exclusion criteria
Exclusion criteria: Going to the acute phase of the disease means a 20% increase in the overall score of PANSS (Scizospheria positive and negative evaluation criteria) Patients with acute suicidal behavior or a history of suicide last year, associated psychiatric disorders such as schizo-effective or other psychotic disorders, mental retardation or other cognitive impairment, bipolar disorder and depression, anxiety disorders such as current panic disorder or obsessive-compulsive disorder, Post-traumatic stress disorder, eating disorder History of substance abuse dependence (substance dependence criteria DSM-5) or abuse of substances in the three months prior to the start of the study or positive urine screening test for the substance at the beginning of the study. Patients under ECT in the last six months People with thoughts or actions to harm themselves or others during the study or in the 6 months before the study Patients with neurological disorders such as dementia, delirium, uncontrolled seizures, head trauma, seizure disorder (other than fever-related) and neurodegenerative diseases (such as Alzheimer's, Parkinson's, Stroke, and multiple sclerosis) People with conduction disorders of the heart and other medical / uncontrolled underlying diseases Patients with a history of NMS Patients treated with drugs that affect the patient's cognitive status are based on the criteria of Drugs on the Anticholinergic Burden (ACB) scale (17), such as drugs with anticholinergic properties (except biperidin and trihexifenidyl), hypnotic antihistamines. , Antidepressants Patients with sensitivity to androsterone or other components of the drug or placebo Patients with endangered drug use in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of general, positive and negative symptoms with Positive and Negative Symptom Scale (PANSS). Timepoint: At baseline and the end of each month. Method of measurement: Positive and Negative Symptom Scale (PANSS).;Score of change in severity of illness based on Clinical Global Impression – Improvement (CGI-I). Timepoint: At the end of each month. Method of measurement: Clinical Global Impression -Improvement (CGI-I) score.;Score of severity of illness based on Clinical Global Impression of Severity (CGI-S). Timepoint: At baseline and at the end of each months. Method of measurement: Clinical Global Impression off Severity (CGI-S).;Score of depression symptoms based on Calgary Depression Scale for Schizophrenia. Timepoint: At baseline and at the end of each months. Method of measurement: Brief Assessment of Cognition in schizophrenia.;Score of SAS for extra pyramidal side effects. Timepoint: At baseline and at the end of each months. Method of measurement: Simpson-Angus Scale (SAS).;Score of Barnes Akathisia Rating Scale (BARS). Timepoint: At baseline and at the end of each months. Method of measurement: Barnes Akathisia Rating Scale (BARS).;Score of Abnormal Involuntary Movement Scale (AIMS). Timepoint: At baseline and at the end of each months. Method of measurement: Abnormal Involuntary Movement Scale (AIMS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNarjes Hendouei
Mazandaran University of Medical Sciences
Outcome results
None listed