se of bioavailable form of Folic acid for Treatment of Depressio
- Conditions
- Health Condition 1: null- Depression
- Registration Number
- CTRI/2017/03/008255
- Lead Sponsor
- Director Principal Government medical college and hospital Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 67
1) Patients with primary diagnosis of moderate to severe depression according to ICD-10 DCR criteria. These patients should be treatment naïve or if receiving treatment should have regular compliance to it for at least 6 weeks and not be responding to the current treatment as defined by response of <50% of global improvement as reported by the patient and the caregivers.
2) Patients having HAM-D score of >=17, at time of intake which indicates at least moderate degree of depression.
3) Patient and his/her relative willing to give informed consent.
1) Breastfeeding, and pregnant females
2) Having a current serious suicide risk, or psychotic symptoms
3) Unstable medical illness requiring concomitant use of other medication including those medications which are known to have depressogenic effect ( corticosteroids, anti-epileptics, beta-blockers, quinolone class of antibiotics, interferons, anti-neoplastic drugs).
4) Having an active substance use disorder within the past 6 months (in terms of fulfilling criteria for substance-harmful use or substance dependence) except nicotine and caffeine use.
5)Having past history of mania/hypomania (including antidepressant-induced), psychotic symptoms, or seizure disorder.
6)Taking vitamins or dietary supplements containing folate or vitamin B12.
7)Having comorbid diagnosis of intellectual disability, dementia, Alzheimerâ??s disease, or Parkinsonâ??s disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method