| CTRI Number |
CTRI/2014/11/005213 [Registered on: 20/11/2014] Trial Registered Prospectively |
| Last Modified On: |
09/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Questionnaire based survey of Psychiatrists to know their treatment options for Bipolar Disorders |
|
Scientific Title of Study
|
A Questionnaire based Survey of Psychiatrists practicing in India to Determine their Diagnostic and Management Practices for Bipolar Disorders in Clinical Practice |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 200017 dated 22 September 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujay Kulkarni |
| Designation |
Senior Manager, Clinical Research |
| Affiliation |
Glaxosmithkline Pharmaceuticals |
| Address |
Glaxosmithkline Pharmaceuticals Limited
Dr Annie Besant Road, Worli, Mumbai
Mumbai MAHARASHTRA 400030 India |
| Phone |
2224959503 |
| Fax |
|
| Email |
sujay.s.kulkarni@gsk.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sujay Kulkarni |
| Designation |
Senior Manager, Clinical Research |
| Affiliation |
Glaxosmithkline Pharmaceuticals |
| Address |
Glaxosmithkline Pharmaceuticals Limited
Dr Annie Besant Road, Worli, Mumbai
MAHARASHTRA 400030 India |
| Phone |
2224959503 |
| Fax |
|
| Email |
sujay.s.kulkarni@gsk.com |
|
Details of Contact Person Public Query
|
| Name |
Samuda Kanakapura |
| Designation |
Clinical Team Leader |
| Affiliation |
Glaxosmithkline Pharmaceuticals |
| Address |
Glaxosmithkline Pharmaceuticals Limited
5, Embassy Links, Cunningham road( SRT road)
Bangalore Glaxosmithkline Pharmaceuticals Limited
Dr Annie Besant Road, Worli, Mumbai Bangalore KARNATAKA 560052 India |
| Phone |
8071117713 |
| Fax |
|
| Email |
samuda.r.kanakapura@gsk.com |
|
|
Source of Monetary or Material Support
|
| Glaxosmithkline Pharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Glaxosmithkline Pharmaceuticals Limited |
| Address |
Dr Annie Besant Road, Worli, Mumbai 400030 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Sujay S Kulkarni |
Glaxosmithkline Pharmaceuticals Limited |
Glaxo House, Dr Annie Besant Road, Worli, Mumbai 400030 Mumbai MAHARASHTRA |
24959503
sujay.s.kulkarni@gsk.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EthicsRUs |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bipolar Disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Questionnaire |
The questionnaire has questions pertaining to diagnosis of BPD; First, second, and third prescription choices for various phases and types of BPD; use of antidepressants for bipolar depression (class, mono-therapy/ combination therapy, efficacy, effect on disease spectrum); prophylactic therapy of BPD; use of Psychoeducation/ Interpersonal and Social Rhythm Therapy/ Electroconvulsive therapy in BPD; and reference to treatment guidelines. |
|
|
Inclusion Criteria
|
| Age From |
27.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Psychiatrists (with postgraduate degree/diploma/fellowship in psychiatry) practicing for at least 3 years after post graduation in India.
2. Psychiatrists willing to sign the consent form
3. Psychiatrists willing to complete the survey
|
|
| ExclusionCriteria |
| Details |
1. Psychiatrists practicing for fewer than 3 years after post graduation in India.
2. Psychiatrists not willing to sign the consent form
3. Psychiatrists not willing to complete the survey questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The usage pattern of pharmacological and non-pharmacological interventions by Psychiatrists practicing in India for bipolar disorders |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Determination of gaps (if any) in CANMAT guidelines and treatment chosen in the clinical practice in India
2. Determination of the extent of use of antidepressants in bipolar disorder by psychiatrists practising in India
3. Determination of the role of Psychoeducation, Interpersonal and Social Rhythm Therapy or ECT in BPD by psychiatrists practising in India
|
2 months |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bipolar Disorder is a serious disorder of mood that is associated with considerable psychosocial and economic morbidity. Misdiagnosis of the illness as recurrent unipolar depression is common, leading to initiation of medicines that adversely affect the condition’s course. Despite their widespread use, considerable uncertainty and controversy remains about the use of antidepressant drugs in the management of depressive episodes.
There are limited data from India to suggest whether availability of newer options [atypical antipsychotics (mono/combination with mood stabilizers), antiepileptic agents (for acute mania), and psychosocial interventions for maintenance] have reflected in prescription behaviour of psychiatrists in treatment of BPD. Moreover, India specific data are missing with reference to treatment recommended in guidelines and prevailing in the clinical practice.
There is significant unmet medical need in understanding various important aspects in the management of BPD such as treatment of different phases of BPD; place of combination medications; treatment for mixed states, hypomania, rapid cycling; place of antidepressants in treating bipolar depression; use of psychological therapies and electroconvulsive therapy (ECT); etc. At present, there are scarce published data on the prevalent diagnostic and treatment practices for patients suffering from BPD among psychiatrists practicing in India. Hence, this study will be conducted to gather data on prescription patterns of psychiatrists practicing in India for acute and maintenance phases of BPD and identify gaps (if any) between guideline recommendations and treatments most frequently chosen by them. |