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

Role of Genomic Biomarkers in predicting prophylactic response to Lithium in Paediatric-onset Bipolar Disorder - LiPBD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/09/009836
Enrollment
690
Registered
2017-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Nil: Patients started on Lithium as part of treatment as usual will be recruited. Single arm. Based on response status at the end of 2 years, they will be grouped as responders and non-

Sponsors

SERB Department of Science and Technology Government of India
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Frequency of adverse drug reactions in paediatric onset bipolar disorder.Timepoint: 6 monthly for the prospective sample.

Countries

India

Contacts

Public ContactPreeti Kandasamy

JIPMER

preetikandasamy@gmail.com9843443140

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026