Comparison of the effectiveness of intramuscular olanzapine with intramuscular haloperidol for the treatment of agitation in patients with Bipolar Disorder, A randomized controlled study.
patients are transferred to one of the two women wards of the Razi hospital in Tehran based on the capacity of the wards and in turn, to control the agitation, in one of the two wards, the Olanzapine and in the other ward the Haloperidol were provided to the staff
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having an overall score of 14 and above in PANSS and having a score of 4 (max 7) in at least one of its five cases. No physical illness associated with mental retardation or other cognitive and neurological disorders and patients with a history of NMS. No dependence or abuse of substances, drugs or alcohol
Exclusion criteria: 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. 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 benzodiazepines within the last 4 hours. Patients who have received oral or rapid muscular antipsychotics in the last 2 hours
Intervention groups
Samples will be selected from patients between 18 and 65 years old admitted to the psychiatric ward of Razi Hospital in 1401 who have a diagnosis of bipolar disorder. Patients are transferred to one of the two wards of the women's hospital. In order to control the agitation, in one of the two wards, Olanzapine and in the other part of the injectable
Haloperidol were provided to the staff
Main outcome variables
PANSS ؛ RASS ؛ MSAS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230131057294N1
Registration date:2024-02-25, 1402/12/06
Registration timing:prospective
Last update:2024-02-25, 1402/12/06
Update count:0
Registration date
2024-02-25, 1402/12/06
Registrant information
Name
Marzieh Khodaparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4445 2713
Email address
marzieh.kh1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-06-09, 1403/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intramuscular olanzapine with intramuscular haloperidol for the treatment of agitation in patients with Bipolar Disorder, A randomized controlled study.
Public title
Comparison of the effectiveness of intramuscular olanzapine with intramuscular haloperidol for the treatment of agitation in patients with Bipolar Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old to 65 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of The University of Rehabilitation Sciences and Social Health
Street address
At the end of 6th St.,Velenjak,Tehran
City
tehran
Province
Tehran
Postal code
1985713871
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.USWR.REC.1402.244
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Positive and Negative Symptom Scale score
Timepoint
15 minutes, 1 hour and 24 hours later
Method of measurement
Positive and Negative Symptom Scale
2
Description
Modified Simpson-angus scale score
Timepoint
15 minutes, 1 hour and 24 hours later
Method of measurement
Modified Simpson-angus scale
3
Description
Richmond Agitation-Sedation Scale score
Timepoint
15 minutes, 1 hour and 24 hours later
Method of measurement
Richmond Agitation-Sedation Scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.