Skip to content

Cyproheptadine for prevention of neuropsychiatric adverse effects of antiretrovirals including efavirenz

Randomized placebo controlled trial of cyproheptadine for prevention of neuropsychiatric adverse effects of antiretroviral including efavirenz.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201103106026N1
Enrollment
50
Registered
2011-05-01
Start date
2011-11-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Human immunodeficiency virus [HIV] disease. Human immunodeficiency virus [HIV] disease resulting in other conditions

Interventions

Intervention 1: Interventional group: cyproheptadine, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine, oral tablet 4 mg, 3 tablets at night for other 3 weeks. Intervention 2: Control gr
Treatment - Drugs
Placebo
Interventional group: cyproheptadine, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine, oral tablet 4 mg, 3 tablets at night for other 3 weeks
Control group: cyproheptadine placebo, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine placebo, oral tablet 4 mg, 3 tablets at night for other 3 weeks

Sponsors

Vice-Chancellor for Research,Tehran University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with HIV-1 infection, older than 18 years who are scheduled to receive an efavirenz-containing treatment Exclusion criteria: Pervious treatment with antiretroviral drugs including efavirenz, pregnancy, use of other medications that be effective on patient‘s mood such as methadone and having major psychiatric disorders like depression at the beginning of this study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Neuropsychiatric effects of efavirenz. Timepoint: Before intevention, 4 weeks after intervention. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Appetite. Timepoint: Before intevention, 4 weeks after intervention. Method of measurement: Questionnaire.;Weight. Timepoint: Before intevention, 4 weeks after intervention. Method of measurement: Weight scale.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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