Valerian for prevention of neuropsychiatric adverse effects of Efavirenz in HIV positive patients
Phase 2
- Conditions
- europsychiatric disorders.A cluster of psychotic phenomena that occur during or following drug useF10-19.5
- Registration Number
- IRCT201504053449N18
- Lead Sponsor
- Vice Chancellor for Research, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients with confirmed HIV infection, between 18-65 years old, receiving Efavirenz containing antiretroviral treatment.
Exclusion criteria:
Pregnant and lactating women, previous treatment with Efavirenz, positive history of neuropyschiatric disorders such as severe depression, patients who are receiving mood affecting agents (such as Methadone), positive history of hypersensitivity to herbal products including Valerian, discontinuation of antiretroviral therapy by patient due to any reason, patients who do not tolerate side effects of Valerian (headache, vertigo, stomach pain, nausea, vomiting, diarrhea and palpitation).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression, Anxiety, Sleep Disturbance. Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis. Timepoint: At baseline and 4 weeks later. Method of measurement: The Hamilton Depression and Anxiety, Pittsburgh Sleep Quality, Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis Scales.
- Secondary Outcome Measures
Name Time Method Safety of Valerian. Timepoint: During the study. Method of measurement: Patients reports and follow up.