Last updated: 02/19/2019 21:20:21

A Questionnaire based Survey of Psychiatrists practicing in India to Determine their Diagnostic and Management Practices for Bipolar Disorders in Clinical Practice

GSK study ID
200017
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Questionnaire based Survey of Psychiatrists practicing in India to Determine their Diagnostic and Management Practices for Bipolar Disorders in Clinical Practice
Trial description: Bipolar Disorder (BPD) 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The usage pattern of pharmacological and non-pharmacological interventions by Psychiatrists practicing in India for bipolar disorders

Timeframe: 2 months

Secondary outcomes:

Determination of the extent of use of antidepressants in bipolar disorder by psychiatrists practising in India

Timeframe: 2 months

Determination of gaps (if any) in Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines and treatment chosen in the clinical practice in India

Timeframe: 2 months

Determination of the role of Psychoeducation, Interpersonal and Social Rhythm Therapy or ECT in BPD by psychiatrists practising in India

Timeframe: 2 months

Interventions:
  • Other: Questionnaire
  • Enrollment:
    500
    Primary completion date:
    2015-14-07
    Observational study model:
    Ecologic or Community
    Time perspective:
    Prospective
    Clinical publications:
    YCJ Reddy, V Jhanwar, R Nagpal, MS Reddy, N Shah,S Ghorpade, S Kulkarni. Prescribing Practices of Indian Psychiatrists in Treatment of Bipolar Disorder. Aust N Z J Psychiatry. 2018;53(5):458-469 DOI: 10.1177/0004867419826718 PMID: 30727750
    Medical condition
    Bipolar Disorder
    Product
    lamotrigine
    Collaborators
    Society for Bipolar Disorders, India
    Study date(s)
    December 2014 to July 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    yes
    • Psychiatrists (with postgraduate degree/diploma/fellowship in psychiatry) practicing for at least 3 years after post graduation in India.
    • Psychiatrists willing to sign the consent form
    • Psychiatrists practicing for less than 3 years after post graduation in India.
    • Psychiatrists not willing to sign the consent form

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-14-07
    Actual study completion date
    2015-14-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website