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IRCT20101108005138N4 IRCT 2019-07-08 Mazandaran University of Medical Sciences Evaluation of Varenicline on cognitive impairement in patient with schizophrenia Study of the efficacy and safety of varenicline as an adjuvant to antipsychotics in patients with schizophrenia on cognitive impairment : A randomized control trial 2018-09-22 anticipated 96 Complete https://irct.ir/trial/39961 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on random numbers and 1: 1 ratio in treatment group and control group, Blinding description: varenicline and placebo tablets are completely similar in terms of color, size, smell and taste produced by a completely similar manufacturing and packagings. Patients were randomly tested in groups. Until the end of the study, no patient or study persons are aware of which drug the patient receives. And anybody other than those who are defective in the study is aware. 3 Schizophrenia with residual symptoms. Intervention 1: Intervention group: treatment regimen with varenicline tablets begin with 0.5 mg at first 3 day and then increase to 0.5 mg bid at the second 3 days and then reach to 1mg at morning and 0.5 mg at night for the third 3 days and from the 10th day, 1mg bid until the end of 2nd month. Intervention 2: Control group: treatment regimen with placebo tablets with the same protocol dose that use for varenicline. The placebo tablets are similar to varenicline tablets for odor, taste, size and color. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet - its release plan is still unclear
public Abbas Masoudzadeh
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 masoudzadeh@yahoo.com Mazandaran University of Medical Sciences scientific Abbas Masoudzadeh
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 masoudzadeh@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients who are hospitalized in psychiatric centers of the province and are in the range of 18-65 years old. Patients who were diagnosed with schizophrenia based on DSM-5 criteria, got at least two years of anti-psychotic drug treatment but still show symptoms. Patients who are treated with anti-psychotics for at least one year and in the last month, the type and the dosage of anti-psychotics has remained permanent. If the patients receives mood stabilizer drugs and antidepressants with their anti-psychotic treatment, the type and the dosage of the drug will remain constant for one month before the study and during the study. Consent from patient's guardian. 18 years 65 years Both Patients with suicidal thoughts and acute suicidal behavior, a history of suicidal thoughts or attempted suicide during the past year, patients with thoughts or attempts to harm themselves or others at the beginning of the study or 6 months before the study, serious illness, major depression during the last 12 months that requires treatment, a history of hospitalization due to the episode of major depression over the past 6 months. Patients who received ECT during the last 6 months. Patients who suffer from psychiatric disorders such as schizophrenia or other psychiatric disorders' bipolar disorder, anxiety disorders such as panic disorder or obsessive-compulsive disorder, post traumatic stress disorder, eating disorder. Current or past (past 6 months) diagnosis, severe personality disorders that compromise the ability of participants to fulfill the study requirements Dependence or acute drug, substance or alcohol abuse in the past 12 months, except nicotine (DSM-5) or positive urine specimen testing at the beginning of the study Acute phase of the disease ((an increase of 20% in the total score of PANSS) criteria for assessing the positive and negative symptoms of schizophrenia) Sensitization to varenicline or other substances in the placebo Other treatments that can interfere with the results. for example quit smoking (bupropion, varicellin or nicotine), the use of varnicline and other medication less than 30 days before the study or during the study. patients treated with anticholinergic drugs (except bipyridine and trihexafenidil) based on ACB scale (26) and obtaining the history of the drugs patient used. Physical illness, mental retardation or other cognitive impairment and neurological disorders such as delirium dementia, uncontrolled bleeding, head injury, seizure disorder (other than the febrile type), and neurodegenerative diseases (such as Alzheimer's, Parkinson's disease , Stroke, and multiple sclerosis), and severe cardiovascular or pertussocular ailments in the past 6 months, recent history of cancer (in the past 5 years), BMI less than 15 kg/m2 or more than 38 kg/m2 or weight more than 45.5 kg or any severe and unstable medical or psychiatric conditions and disorders. uncontrolled ilnesses and patients with NMS. this information can be obtained through PMH. F20.5 Residual schizophrenia Treatment - Drugs Placebo Intervention group: treatment regimen with varenicline tablets begin with 0.5 mg at first 3 day and then increase to 0.5 mg bid at the second 3 days and then reach to 1mg at morning and 0.5 mg at night for the third 3 days and from the 10th day, 1mg bid until the end of 2nd month. Control group: treatment regimen with placebo tablets with the same protocol dose that use for varenicline. The placebo tablets are similar to varenicline tablets for odor, taste, size and color. 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 improvement in cognitive symptoms based on brief assesment of cognition in schizophrenia. Timepoint: At baseline and the end of each month. Method of measurement: Brief assessment of Cognition in schizophrenia. Sari University of Medical Sciences Approved 2018-10-02 Ethics Committee of Mazandaran University of Medical Sciences Moallem street, Moallem square, Vice chancellor for research Sari Mazandaran Iran (Islamic Republic of)