Comparison of the effectiveness of intramuscular olanzapine with intramuscular haloperidol for the treatment of agitation in patients with Bipolar Disorder

Phase 4

• Conditions: Bipolar disorder.; Bipolar disorder

• Registration Number: IRCT20230131057294N1
• Lead Sponsor: niversity of social welfare and rehabilitation sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified