FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
None   
 
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  
Status 
Not Applicable 
 
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.

 
Close