| CTRI Number |
CTRI/2024/06/068858 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The efficacy of adding vitamin D to sertraline for the treatment of anxiety disorders |
|
Scientific Title of Study
|
Effectiveness of Vitamin D augmentation to Sertraline in treatment of Anxiety Disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prakrati Ratiya |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9460472566 |
| Fax |
0172-2609360 |
| Email |
prakrati7890@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Arun |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9646121612 |
| Fax |
0172-2609360 |
| Email |
drpritiarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakrati Ratiya |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9460472566 |
| Fax |
0172-2609360 |
| Email |
prakrati7890@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, 160032 Chandigarh, Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Government Medical College and Hospital, Sector 32, Chandigarh, CHANDIGARH, 160032, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakrati Ratiya |
Govenment Medical College and Hospital |
Room no 4212, Level 4, B block, Govenment
Medical College and
Hospital, Sector 32,
Chandigarh
Chandigarh
CHANDIGARH |
9460472566
-
prakrati7890@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F41||Other anxiety disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sertraline only |
Selective Serotonin Reuptake Inhibitor. Tablet Sertraline will be started with 25mg/day which will be optimised between dose range 50-200mg/day as per NICE guidelines depending on response and side effects. Time period of study will be 8 weeks and patients will be assessed and managed accordingly every 2 weeks. |
| Intervention |
Sertraline plus Vitamin D |
Selective Serotonin Reuptake Inhibitor and Nutraceutical respectively. Tablet Sertraline will be started with 25mg/day which will be optimised between dose range 50-200mg/day as per NICE guidelines depending on response and side effects. Vitamin D3 60,000IU orally once per week will be started as per ICMR guidelines added to ongoing prescription of Setraline. Time period of study will be 8 weeks and patients will be assessed and managed accordingly every 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with a primary diagnosis of Anxiety or fear related disorders as per ICD-11
(which includes patients diagnosed with Generalized Anxiety Disorder, Panic Disorder,
Agoraphobia, Specific Phobia, Social Anxiety Disorder, Separation Anxiety Disorder,
Selective Mutism, Other Specified Anxiety or Fear-Related Disorders).
2.Age group of 18-65yrs.
3.Any gender.
4.Vitamin D levels between 30nmol/L-75nmol/L.
5.Not on any psychotropic medication for current episode of illness
6.Patients having the capacity to give informed written consent as per section 4 of MHCA,
2017. |
|
| ExclusionCriteria |
| Details |
1. Patients with an active substance use disorder within the past 6 months(in terms of
fulfilling the ICD-11 criteria for substance dependence) except caffeine and nicotine.
2. Patients with any acute medical or surgical illness, anaemia, thyroid disoders.
3. Pregnant and lactating females.
4. Acutely violent patients or those having a current serious suicide risk.
5. Taking vitamins or dietary supplements containing vitamin D in last 3 months.
6. History of treatment resistance/poor response or major side-effects with SSRIs.
7. Having co-morbid diagnosis of intellectua ldisability, dementia, Alzeihmer‟s disease,
Parkinsons disease, Epilepsy.
8. Other co-morbid psychiatric illnesses including Schizophrenia, mood disorders,
Obsessive compulsive and related disorder, disorders associated with stress (including
PTSD and adjustment disorders), sleep disorders, eating disoders. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
0, 2, 4, 6, 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate vitamin D levels with severity of anxiety disorders. |
0, 2, 4, 6, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |