Relationship between valproate levels in blood and its therapeutic effects in patients with Mania

Not yet recruiting

Conditions: Bipolar disorder, current episodemanic severe with psychotic features,

Brief Summary: Sodium valproate is a very commonly used Mood stabiliser in the indian tertiary care setting. Previous studies done on the serum concentration ranges of valproate that produces satisfactory clinical outcome has revealed conflicting information.Most of these studies have used assay methods, In this study we are using a standardised LCMS-MS method to ascertain the levels.The clinical outcome is measured by Young Mania Rating Scale and adverse effect will be noted down. Serum sample will be collected after patient is on valproate for atleast 5 days. The clinical outcome and advese effect will be correlated with the serum valproate levels.

Research question

What is the serum valproate concentration range for satisfactory clinical outcome in patients with bipolar disorder treated with sodium valproate?

Recruitment & Eligibility

Inclusion Criteria

Manic phase of Bipolar disorder Recieving sodium valproate.

Exclusion Criteria

Recieving concomitant Lithium and Carbamazepine therapy, Substance abuse, organic mood disorder, seizure disorder.

Primary Outcome Measures

Name	Time	Method
Clinical outcome measured with Young Mania Rating Scale score	During admission period

Secondary Outcome Measures

Name	Time	Method
Adverse effects	During admission period

Locations (1): JIPMER Pondicherry
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER Pondicherry
🇮🇳Pondicherry, PONDICHERRY, India
Dr Vishnu Eriyat
Principal investigator
9037823770
eriyatvishnu@gmail.com