se of genetic test in finding the treatment effect in patients with bipolar disorder.

Not Applicable

Completed

• Conditions: Health Condition 1: F31- Bipolar disorderHealth Condition 2: null- Patients with Pediatric onset Bipolar disorder and controls.

• Registration Number: CTRI/2017/09/009836
• Lead Sponsor: SERB Department of Science and Technology Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 284

Inclusion Criteria

Retrospective:

1)Patients with the diagnosis of bipolar disorder as per DSM 5 diagnostic criteria of South Indian origin.

2)Age at onset of first episode before 18 years.

3)Patients who are on regular treatment with Lithium.

4)On follow up for a minimum of 2 years.

Prospective

1)Patients with the diagnosis of bipolar disorder as per DSM 5 diagnostic criteria of South Indian origin.

2)Age at onset of first episode before 18 years.

3)Patients who are started on Lithium as part of treatment as usual.

4)Who are willing for 6 monthly follow up for a minimum of 2 years after stabilization of treatment.

Controls: Unrelated healthy controls of either gender of South Indian origin above 18 years of age without family history of Bipolar disorder.

Exclusion Criteria

Retrospective:

1)Patients with comorbid Intellectual disability or Autism spectrum disorder

2)Patients with Organic Bipolar disorder

Prospective:

1)Patients with comorbid Intellectual disability or Autism spectrum disorder.

2)Patients with Organic Bipolar disorder

3)Adult female patients who are planning for pregnancy, currently pregnant or lactating.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify genomic bio-markers associated with prophylactic response to lIthium to improve predictability of treatment response in paediatric onset Bipolar disorder.Timepoint: At the end of 2 years.

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse drug reactions in paediatric onset bipolar disorder.Timepoint: 6 monthly for the prospective sample.