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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.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230131057294N1
Enrollment
40
Registered
2024-02-25
Start date
2024-04-08
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder. Bipolar disorder

Interventions

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

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Khodaparast

University of social welfare and rehabilitation sciences

marzieh.kh1994@gmail.com+98 21 4445 2713

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026