Effectiveness of Vitamin D augmentation to Sertraline in treatment of Anxiety Disorders

Patients aged 18-65yrs presenting to Outpatient clinic of Department of Psychiatry, Government Medical College and Hospital, sector-32, Chandigarh diagnosed with Anxiety & fear related Disorder as per criteria of ICD-11, and willing to give written informed consent for participation in the study will be screened for serum vitamin D levels. Baseline investigations- Hemogram, Liver Function Test, Renal Function Test, fasting blood sugar and serum vitamin D levels, thyroid function tests, serum calcium, serum vitamin B12 will also be done in all patients. Till the reports of serum vitamin D are awaited, all the patients will be started on treatment (Sertraline 25mg/day). Those with serum vitamin D levels between 30-75nmol/L after meeting inclusion and exclusion criteria will be recruited for the study which will be of 8 weeks duration. Those with levels less than 30nmol/L indicating vitamin D deficiency, or with any other derangements in baseline parameters indicating medical illness will be referred to medicine/endocrinology department for appropriate management. Sociodemographic and clinical details of the patients will be recorded. A baseline assessment for symptoms of anxiety disorder will be done by applying HAM-A scale. Other scales: HDRS-17, CGI-S, SF-12 will be applied. The patients will then be divided into two groups, Group A or the study group and Group B or the control group, using computer generated random tables. Patients in group A will be started on Vitamin D3 60,000 IU orally once per week as per ICMR- guidelines, added to their ongoing prescription of Sertraline. Oral vitamin D will be taken in the form of tablet/sachet of granules of cholecalciferol (VitaminD3). Patients in group B will be continued on Sertraline only. In group B, patients with S. Vitamin D levels between 30-50nmol/L, indicating insufficiency or mild deficiency, will be given vitamin D supplementation after completion of study period i.e 8 weeks. In both groups, Tab. Sertraline 25mg/day will be gradually optimized between the dose range of 50-200mg/day, (as per the NICE guidelines) depending on the response and side-effects. Response will be defined as more than 50% decrease in scores of HAM-A scale when compared to baseline. Assessment of severity and side-effects will be measured every two weeks by applying HAM-A and side-effect checklist (2, 4, 6 and 8 week of study). HDRS-17 will also be applied every two weeks, while the scales measuring quality of life and global improvement will be applied at end of study period of 8 weeks. Concomitant use of Benzodiazepines (Clonazepam, Etizolam) will be allowed sparingly, only if necessary (on SOS basis) in both the groups and will be documented in the study. Any other form of non-pharmacological treatment which forms a part of standard of care (like relaxation exercises) will be allowed in both groups. If during the follow up visit, the patient requests a change in the management before the end of 8 weeks, they will be dropped out of the study and will be managed accordingly. Also, if any patient develops intolerable side effects to Vitamin D supplementation they will be dropped from study and managed accordingly. If a patient develops side-effects with T. Sertraline, the dosage will be down titrated and if side effects still persist, he/she will be dropped out of study and managed clinically. Blood investigations to check levels of Vitamin D, Calcium will be done at the end of 8 weeks. Any patient having a deficiency of these parameters will be referred to medicine department for management. Outcome parameters of the study would be: ï‚· To compare the reduction in severity of anxiety in study group (receiving vitamin D plus standard of care (SOC)) & control group (receiving SOC only) as measured on 1. HAM-A 2. HDRS-17 3. CGI ï‚· To correlate vitamin D levels with severity of anxiety disorders.