Risperidone and Clonazepam combined by oral solution with intramuscular Haloperidol Agitation by Psychosis

Comparison of Risperidone and Clonazepam combined by oral solution with intramuscular Haloperidol as monotherapy in psychomotor agitation of psychotic patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-8s8tz32

Enrollment

Unknown

Registered

2023-08-16

Start date

2023-12-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Psychomotor agitation

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial.Male patients, aged 18 to 50 years, will be recruited after their relative signs the consent form. He will then be selected to rec

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Eligibility

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients in psychomotor agitation scored by the Behavioral Activity Rating Scale (BARS)=6; who did not use any psychoactive drugs in the last 7 days; with mental illness; patients with psychotic disorder or bipolar disorder; age between 18 and 50 years old; both sexes

Exclusion criteria

Exclusion criteria: Acute intoxication states; delirium; withdrawal syndrome; mental disorder of organic origin; refusal to participate in the research

Design outcomes

Primary

Measure	Time frame
Outcome expected 1: greater proportion (more than 10%) of patients with scores on the Behavioral Activity Rating Scale (BARS) equal to 4 (calm) at 1 hour and 2 hours after the first medication for the group using risperidone associated with clonazepam in oral solution;Outcome found 1: Considering as the main outcome being calm all the time (BARS=4 in all assessments), risperidone 3mg plus clonazepam 3mg (both oral solution) had a rate of 16.9% and intramuscular haloperidol 5mg 20.8%. The difference was -3.8 ± 4.8, Z=-0.793, p=0.428. Therefore, for this outcome, RC can be considered equivalent to IH, although the response was low.	—

Measure

Time frame

Outcome expected 1: greater proportion (more than 10%) of patients with scores on the Behavioral Activity Rating Scale (BARS) equal to 4 (calm) at 1 hour and 2 hours after the first medication for the group using risperidone associated with clonazepam in oral solution;Outcome found 1: Considering as the main outcome being calm all the time (BARS=4 in all assessments), risperidone 3mg plus clonazepam 3mg (both oral solution) had a rate of 16.9% and intramuscular haloperidol 5mg 20.8%. The difference was -3.8 ± 4.8, Z=-0.793, p=0.428. Therefore, for this outcome, RC can be considered equivalent to IH, although the response was low.

—

Secondary

Measure	Time frame
Outcome expected 2: 10% of proportion of patients with with side effects in the group using risperidone associated with clonazepam in oral solution;Outcome found 2: For risperidone plus clonazepam tachycardia (8 patients, 6,7%). For intramuscular haloperidol only extrapyramidal side effects (dystonia, 2 patients, 1,7%). There is no case of excessive sedation (BARS=1).	—

Countries

Brazil

Contacts

Public ContactLeonardo Baldaçara

Universidade Federal do Tocantins

leonardobaldassara@gmail.com+55(63)3228-1807

Outcome results

None listed

Source: REBEC (via WHO ICTRP)