Risk of heart disease with six-month use of anti-depressants (Selective Serotonin Reuptake Inhibitor)
- Registration Number
- CTRI/2018/10/016035
- Lead Sponsor
- All India Institute of Medical Sciences Raipur Chhattisgarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Newly diagnosed patients of Depression/ Anxiety/ OCD/ Somatoform disorder who will be started on SSRI therapy
2) Those who will consent to participate
1) History of anti-psychotic treatment (olanzapine, quetiapine, ziprasidone, risperidone, aripiprazole)
2) History of substance abuse (amphetamines, cocaine, ecstasy)
3) Pregnant women
4) History of use of drugs which either increase body weight/ BMI/ promote atherosclerosis (TCAs, OCPs, MAOIs, Corticosteroids, Anti-epileptics)
5) Any patient who is concurrently using statins
6) Any patient with depression following cerebrovascular accident
7) Any patient with Thyroid disease/ newly diagnosed with thyroid disease
8) Any patient with dyslipidemia
9) Any patient with BMI of overweight (25.0-29.9) or obese (>= 30.0)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients with at least 5% increase in total cholesterol level from baselineTimepoint: First Visit (Baseline, 0 weeks) <br/ ><br>Second Visit (12th week) <br/ ><br>Third Visit (24th week)
- Secondary Outcome Measures
Name Time Method umber of patients showing increase in BMI, waist circumference, waist hip ratio and CRP, and irregularities in ECG from the baseline at the end of six-month follow-up.Timepoint: First Visit (Baseline, 0 weeks) <br/ ><br>Second Visit (12th week) <br/ ><br>Third Visit (24th week);Number of patients showing increased Apolipoprotein B100 from the baseline at the end of six-month follow-up.Timepoint: First Visit (Baseline, 0 weeks) <br/ ><br>Third Visit (24th week)