Effect of Oral and Injectable Risperidone on Prolactin in Psychotic Patients

Comparison of Serum Prolactin Concentrations after Administration of Long-Acting Injectable Risperidone and Oral Risperidone Tablets in Patients with Psychotic Disorders

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221003056082N1

Enrollment

Registered

2023-01-11

Start date

2023-02-04

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

The effect of oral and injectable risperidone on serum prolactin level.

Interventions

Intervention 1: The first intervention group: Oral risperidone 2 mg two or three times a day for two weeks. Intervention 2: The second intervention group: Long-acting injectable risperidone 25 mg on t

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 18 to 60 years Having a psychotic disorder No mood disorder A candidate for antipsychotics Not using antipsychotic drugs in the last year Patient satisfaction and cooperation

Exclusion criteria

Exclusion criteria: Patients with high prolactin levels Patients with hypothyroidism Patients with impaired liver or kidney tests Pregnant women

Design outcomes

Primary

Measure	Time frame
Serum prolactin level. Timepoint: Before starting the treatment and on the first day, the seventh day and the fourteenth day after starting the treatment with oral or injectable risperidone. Method of measurement: Prolactin laboratory kit.	—

Secondary

Measure	Time frame
Fasting blood sugar. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Blood sugar laboratory kit.;Blood triglycerides. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Triglyceride laboratory kit.;Blood cholesterol. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Cholesterol laboratory kit.	—

Measure

Time frame

Fasting blood sugar. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Blood sugar laboratory kit.;Blood triglycerides. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Triglyceride laboratory kit.;Blood cholesterol. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Cholesterol laboratory kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Ali Nazriastaneh

University of social welfare and rehabilitation sciences

a.nazeri@uswr.ac.ir+98 21 7173 2000

Outcome results

None listed

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