A clinical study to assess the effects of antidepressant drugs on orexin in patients with major depressive disorder
Not Applicable
- Conditions
- Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified
- Registration Number
- CTRI/2024/05/066840
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adult males or females aged 18 to 65 with the diagnosis of Major Depressive Disorder (MDD)
2. Patients who are drug naive or have started on antidepressant therapy for less than 2 weeks
Exclusion Criteria
Patients with any known neurological or any systemic disorders known to cause major depressive disorder
Patients with any other psychiatric illness and substance use disorders
Pregnant and lactating women
Patients not willing to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean serum orexin <br/ ><br>Timepoint: At baseline and 6-12 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Orexin and BDNF gene variants <br/ ><br>Mean Montgomery Asberg Depression rating score <br/ ><br>Mean PSQI sleep score <br/ ><br>Mean MoCA score <br/ ><br>Mean serum orexin <br/ ><br>Mean serum BDNF <br/ ><br>Metabolomic profile mean metabolite levelsTimepoint: Week 1