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IRCT20190905044703N1 IRCT 2019-10-05 Kerman University of Medical Sciences Effect of buprenorphine on the treatment of psychosis in bipolar patients with psychotic symptoms Effect of buprenorphine on the treatment of psychosis in bipolar patients with psychotic symptoms 2019-10-12 anticipated 60 Complete https://irct.ir/trial/42141 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study 60 patients will be randomly divided into two treatment groups. The way to select groups is that they will be assigned to groups based on block randomization. Block size 4 is considered. So we will have six blocks containing BBAA, ABAB, BABA, AABB, ABBA, BAAB. Each block will also be randomly selected using a dice throw. For example, if dice 4 is thrown, the AABB block is considered, so the first two patients are assigned to treatment A and the next two patients to treatment B. The dice will be thrown 15 times to complete the patient assignment to the treatment groups. The treatment will also be assigned to the treatment and control groups based on the accident (coin toss), Blinding description: We randomly divided the treatment groups (sublingual buprenorphine) and the control group (placebo tablets) so that patients in these groups were unaware of the treatment assignment and the treating physician of these patients was unaware of the treatment assignment in the groups. 3 Psychosis. Intervention 1: Intervention group: Intervention group: Intervention group, sublingual buprenorphine 1 to 2 mg as needed, clonazepam 1 or 2 mg as needed, three gabapentin 300 mg daily, clonidine 0.2 half daily twice or thrice if needed. Tolerate the side effects. Intervention 2: Control group: Control group: Control group will receive the above drugs except sublingual buprenorphine and will be given placebo (made by buprenorphine tablet manufacturer. To be. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Unclear completion time
public Ali Bamani Glena Abadi
Kerman, Republic Boulevard, Agriculture Boulevard, Shahid Beheshti Hospital
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3211 0408 alibemani1355@gmail.com Kerman University of Medical Sciences scientific Ali Bamani Glena Abadi
Kerman, Republic Boulevard, Agriculture Boulevard, Shahid Beheshti Hospital
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3211 0408 alibemani1355@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 Diagnosis of type 1 BMD (Depression episode, Mania with Psychotic Leader) (based on DSM-V criteria) Initial Severity of Positive Symptoms: BPRS psychotic score with a score of 12 or greater and at least two BPRS psychotic items with a score of 4 or more 18 years 65 years Both A history of methamphetamine use within the last 3 months Alcohol dependence or benzodiazepines or hallucinogenic substances Diagnosis of methamphetamine-induced sustained psychosis F15 Other stimulant related disorders Treatment - Drugs Placebo Intervention group: Intervention group: Intervention group, sublingual buprenorphine 1 to 2 mg as needed, clonazepam 1 or 2 mg as needed, three gabapentin 300 mg daily, clonidine 0.2 half daily twice or thrice if needed. Tolerate the side effects Control group: Control group: Control group will receive the above drugs except sublingual buprenorphine and will be given placebo (made by buprenorphine tablet manufacturer. To be. Psychosis leaderboard. Timepoint: The first day before the intervention and the fourth day after the intervention. Method of measurement: interview. Kerman University of Medical Sciences Approved 2018-06-27 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Vice Chancellor for Research and Technology, Ibn Sina Ave. Kerman East Azarbaijan Iran (Islamic Republic of)