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IRCT20230131057294N1 IRCT 2024-02-25 University of social welfare and rehabilitation sciences Comparison of the effectiveness of intramuscular olanzapine with intramuscular haloperidol for the treatment of agitation in patients with Bipolar Disorder Comparison of the effectiveness of intramuscular olanzapine with intramuscular haloperidol for the treatment of agitation in patients with Bipolar Disorder, A randomized controlled study. 2024-04-08 anticipated 40 Complete https://irct.ir/trial/68356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In psychiatric patients (women) on arrival to Razi Psychiatric Hospital, according to the capacity of wards and in turn, by admission and emergency staff, are transferred to one of the two wards of the hospital. (In the reception system of patients in the emergency room of Razi psychiatric hospital, patients who need to be admitted to one of the two wards of the hospital according to the psychiatrist's diagnosis, are referred to one of the two wards of gynecology by the reception officer) in each of those wards, one of two drugs A or B (haloperidol or olanzapine) is used to control the agitation of patients, Blinding description: For double-blind research, a label is attached to the injected drugs in each part so that the name of the drugs is not seen. One part A and the other is written on the drug B. Neither the patient nor the researcher is aware of the type of drug A or B. In medical instructions, a or B drug injection is written for each section. At the end of the study, the researcher is informed of the type of drug A and B. 4 Bipolar disorder. Intervention 1: First intervention group: Intramuscular injection of (A or B) Olanzapine 10 mg, maximum 3 doses in 24 hours, second injection after at least 2 hours from the first injection and third injection after at least 4 hours of second injection at discretion, to control the agitation. Intervention 2: Second intervention group: Intramuscular injection of (A or B) Haloperidol 5 or 10 mg, maximum 3 doses in 24 hours, second injection after at least 2 hours from the first injection and third injection after at least 4 hours of second injection at discretion, to control the agitation. 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 No more information
public Marzieh Khodaparast
No. 8, Unit 14, first Mahestan, Besat Blvd, Jannat Abad markazi
Tehran Iran (Islamic Republic of) 1474876897 +98 21 4445 2713 marzieh.kh1994@gmail.com University of social welfare and rehabilitation sciences scientific Marzieh Khodaparast
No. 8, Unit 14, first Mahestan, Besat Blvd, Jannat Abad markazi
Tehran Iran (Islamic Republic of) 1474876897 +98 21 4445 2713 marzieh.kh1994@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Patients with Bipolar Disorder diagnosed based on DSM-5 criteria according to clinical interview of psychiatrist. Having an overall score of 14 and above (up to 35) in PANSS including five cases of tension, uncooperativeness, hostility, poor impulse control and excitement. Having a rating of 4 (max 7) in at least one of the above five The psychiatrist concludes that the patient should be treated with Olanzapine IM injection or Haloperidol No physical illness associated with mental retardation or other cognitive disorders and neurological disorders Not having severe cardiovascular diseases or cerberovascular in the past 6 months, any severe, acute or unstable medical conditions or laboratory disorders and uncontrolled underlying disease No NMS history No dependence or abuse of substances, drugs or alcohol acutely or in the past 12 months except nicotine or positive urine screen test Patient or guardian's consent 18 years 65 years Female Patients with a history of allergic reaction or intolerance to Olanzapine or Haloperidol. Patients with psychomotor restlessness who have not been diagnosed with bipolar disorder. Unwillingness of the patient or the patient's family to participate in the study. Pregnant or nursing women Patients who have received antipsychotics depo-injectable drugs during the last 1 month. Patients who have used psychological stimuli within 1 week. Patients who received oral or injectable benzodiazepines within the last 4 hours. Patients who have received oral or rapid muscular antipsychotics in the last 2 hours. F31 Bipolar disorder Treatment - Drugs Treatment - Drugs First intervention group: Intramuscular injection of (A or B) Olanzapine 10 mg, maximum 3 doses in 24 hours, second injection after at least 2 hours from the first injection and third injection after at least 4 hours of second injection at discretion, to control the agitation. Second intervention group: Intramuscular injection of (A or B) Haloperidol 5 or 10 mg, maximum 3 doses in 24 hours, second injection after at least 2 hours from the first injection and third injection after at least 4 hours of second injection at discretion, to control the agitation. Positive and Negative Symptom Scale score. Timepoint: 15 minutes, 1 hour and 24 hours later. Method of measurement: Positive and Negative Symptom Scale. Modified Simpson-angus scale score. Timepoint: 15 minutes, 1 hour and 24 hours later. Method of measurement: Modified Simpson-angus scale. Richmond Agitation-Sedation Scale score. Timepoint: 15 minutes, 1 hour and 24 hours later. Method of measurement: Richmond Agitation-Sedation Scale. University of social welfare and rehabilitation sciences Approved 2024-01-24 Ethics Committee of The University of Rehabilitation Sciences and Social Health At the end of 6th St.,Velenjak,Tehran tehran Tehran Iran (Islamic Republic of)