Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder

Phase 4

Completed

• Conditions: Bipolar Affective Disorder
• Interventions: Drug: Lithium Carbonate; Drug: Sodium chloride

• Registration Number: NCT04222816
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief Summary

Bipolar affective disorder or manic -depressive psychosis (MDP) is a mood disorder affecting 2.4% of the global population . Lithium is considered as the "gold standard" for the treatment of bipolar disorder but the clinical use of lithium is often restricted due to its narrow therapeutic range and adverse effects.
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Detailed Description

Bipolar affective disorder or manic -depressive psychosis (MDP) is a mood disorder affecting 2.4% of the global population. Lithium is considered as the "gold standard" for the treatment of bipolar disorder but the clinical use of lithium is often restricted due to its narrow therapeutic range and adverse effects.One of the major adverse effects of lithium i...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Study Start: 2020-01-16
• Primary Completion: 2021-12-31
• Status Verified: 2022-01
• Study Completion: 2022-01-07
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients aged 18 -60 years, of either sex with the clinical diagnosis of bipolar disorder (DSM V) who are on maintenance lithium therapy for ≥ 1month and ≤ 6 months.
• Patients with normal serum sodium level (135 -145 mEq/L) and serum lithium in the optimum therapeutic range (<0.6 mEq/ L or >0.8 mEq/ L) .

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Exclusion Criteria

• Patients with comorbidities like other psychiatric disorder s, organicity, substance abuse, personality disorder, intellectual disability and other neurotic disorders .
• Patients with any renal, cardiovascular, neurologica l, endocrinal and hepatic dysfunction.
• Patients suffering from diarrhoea, dehydration
• History of any invasive neurosurgical/ non -invasive neuropsychiatric procedure.
• Medication history of psychoactive or central nervous system depressant drugs.
• Patients who are on NSAIDs, ACE inhibitors, antiarrhythmics, diuretics and neuromuscular blocking agents .
• Pregnant and nursing women .
• Patients with drug/alcohol abuse.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Add-on Sodium chloride	Lithium Carbonate	Sodium chloride 1gm per day per will be prescribed along with Lithium carbonate 800-900 mg per day for 12 weeks.
Lithium carbonate	Lithium Carbonate	Lithium carbonate is prescribed 800-900 mg per day for 12 weeks.
Add-on Sodium chloride	Sodium chloride	Sodium chloride 1gm per day per will be prescribed along with Lithium carbonate 800-900 mg per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Difference in percentage of bipolar patients showing fluctuation in serum lithium level	12 weeks	Serum lithium level will be done by electrolyte analyzer. The patients showing fluctuations ( fluctuation is defined as serum lithium \<0.6 mEq/ L or \>0.8 mEq/ L in maintenance phase) in serum lithium level between the groups over 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Serum sodium	12 weeks	Will be done by electrolyte analyzer.
Serum creatinine	12 weeks	Will be done by autoanalyser.
ECG changes	12 weeks	ECG changes for lithium toxicity (T wave inversion, PR prolongation, QT prolongation), hyponatremia (P wave alterations), hypernatremia (short PR interval and diffuse ST depression) will be looked for
Serum Lithium	12 weeks	Will be done by electrolyte analyzer.
Serum Potassium	12 weeks	Will be done by electrolyte analyzer.
Serum aldosterone	12 weeks	Will be done by commercially available ELISA kit.

Trial Locations

Locations (1)

Aiims Bhubaneswar; 🇮🇳 Khorda, Orissa, India