]>
IRCT20161228031626N6 IRCT 2023-07-15 Ahvaz University of Medical Sciences The effectiveness of adding modafinil drug on negative symptoms of schizophrenic patients The effectiveness of adding modafinil drug on negative symptoms of schizophrenic patients being treated with risperidone or olanzapine 2023-08-01 anticipated 42 Complete https://irct.ir/trial/71095 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to divide patients into two groups, the randomized block method is used. In this method, group A is related to the intervention and group B is considered as the control and is classified into 4 blocks including AABB, ABAB, ABBA, BBAA, BABA, BAAB, according to the selected permutations. The patient is classified into one of the intervention or control groups. Random allocation software was used for randomization, Blinding description: In this study, the project manager and the patient are unaware of which of the two groups will receive which drug or placebo. Medicines and placebos will be similar in terms of shape, color, smell and taste. 2-3 Schizophrenia. Intervention 1: Intervention group: In this group, patients will receive 100 to 200 mg of modafinil per day for 4 weeks in addition to the prescribed antipsychotic treatment (resperidone or olanzapine) they were already taking. Intervention 2: Control group: In this group, in addition to the prescribed antipsychotic treatment, the patients were given a placebo pill that was similar to Modafinil in terms of shape, smell, taste, size and color and was prepared by the Faculty of Pharmacy of Ahvaz University in the same way as the intervention group for 4 weeks will receive. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hatam Boostani
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 boostani-h@ajums.ac.ir Ahvaz University of Medical Sciences scientific Hatam Boostani
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 boostani-h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with schizophrenia based on DSM-5 criteria Schizophrenic patients who have been treated with risperidone or olanzapine. 18 years 65 years Both Taking typical antipsychotic and atypical antipsychotic drugs, except for risperidone and olanzapine, and antidepressants, sodium valproate, lithium, and benzodiazepines. The presence of accompanying psychiatric disorders such as schizoaffective or other psychotic disorders, bipolar disorder, anxiety disorders such as panic disorder or obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder Dependence or abuse of substances, drugs or alcohol, acutely or in the past 12 months, except for nicotine Allergy to Modafinil or any of the placebo ingredients F20 Schizophrenia Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients will receive 100 to 200 mg of modafinil per day for 4 weeks in addition to the prescribed antipsychotic treatment (resperidone or olanzapine) they were already taking. Control group: In this group, in addition to the prescribed antipsychotic treatment, the patients were given a placebo pill that was similar to Modafinil in terms of shape, smell, taste, size and color and was prepared by the Faculty of Pharmacy of Ahvaz University in the same way as the intervention group for 4 weeks will receive Negative symptoms. Timepoint: Before and 4 weeks after the study. Method of measurement: Scale for Assessment of Negative Symptoms (SANS). Ahvaz University of Medical Sciences Approved 2023-07-03 Ethics committee of ahvaz University of Medical Sciences Ahvaz Jondishapur University of Medical Sciences, Esfand ave, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)