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

NCT ID: NCT04222816

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-16
• Study Completion Date: 2022-01-07

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.

In a published case report, Bleiwiss H found that sodium chloride supplementation diminished the adverse effects caused by lithium The literature search also revealed that till date, there is no published clinical study evaluating the effect of dietary intake of sodium in preventing the fluctuations of serum lithium level and lithium toxicity Therefore, a randomized clinical trial has been designed to evaluate the effect of regulated add -on dietary sodium chloride on serum lithium levels in bipolar disorder.

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 is nephrogenic diabetes insipidus which is due to long -term renal dysfunction.

In the initial months of lithium therapy, psychiatrists face difficulty in titrating the dose and stabilizing serum lithium level and this fluctuation of serum lithium level may be due to a lithium-induced sodium depleted state.

In a published case report, Bleiwiss H found that sodium chloride supplementation diminished the adverse effects caused by lithium. 8 In another case report, Tomita et al demonstrated that the change in sodium chloride intake can bring about changes in serum lithium and help in stabilizing the levels of serum lithium concentration.

As all the case reports are from abroad, the effect of dietary sodium on serum lithium level among Indian population is completely unknown. The literature search also revealed that till date, there is no published clinical study evaluating the effect of dietary intake of sodium in preventing the fluctuations of serum lithium level and lithium toxicity. Therefore, a randomized clinical trial has been designed to evaluate the effect of regulated add -on dietary sodium chloride on serum lithium levels in bipolar disorder. This study may help to explore the role of add -on sodium chloride in decreasing the fluctuations in the serum lithium level and improving the clinical outcome of patients with bipolar disorders.

Conditions

Bipolar Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Lithium carbonate

Lithium carbonate is prescribed 800-900 mg per day for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Lithium Carbonate

Intervention Type: DRUG

Lithium carbonate 800-900 mg orally daily for 12 weeks

Add-on Sodium chloride

Sodium chloride 1gm per day per will be prescribed along with Lithium carbonate 800-900 mg per day for 12 weeks.

Group Type: EXPERIMENTAL

Lithium Carbonate

Intervention Type: DRUG

Lithium carbonate 800-900 mg orally daily for 12 weeks

Sodium chloride

Intervention Type: DRUG

Sodium chloride 1gm daily per orally for 12 weeks

Interventions

Lithium Carbonate

Lithium carbonate 800-900 mg orally daily for 12 weeks

Intervention Type: DRUG

Sodium chloride

Sodium chloride 1gm daily per orally for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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) .

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences, Bhubaneswar

OTHER

Sponsor Role: lead

Responsible Party

RITUPARNA MAITI

Additional Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DEBASISH HOTA, DM

Role: STUDY_DIRECTOR

PROFESSOR AND HEAD OF THE DEPARTMENT

Locations

Aiims Bhubaneswar

Khordha, Odisha, India

Countries

India

References

Merikangas KR, Jin R, He JP, Kessler RC, Lee S, Sampson NA, Viana MC, Andrade LH, Hu C, Karam EG, Ladea M, Medina-Mora ME, Ono Y, Posada-Villa J, Sagar R, Wells JE, Zarkov Z. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry. 2011 Mar;68(3):241-51. doi: 10.1001/archgenpsychiatry.2011.12.

Reference Type: BACKGROUND

PMID: 21383262 (View on PubMed)

Bleiweiss H. Salts supplements with lithium. Lancet. 1970 Feb 21;1(7643):416. doi: 10.1016/s0140-6736(70)91550-3. No abstract available.

Reference Type: BACKGROUND

PMID: 4189720 (View on PubMed)

Tomita T, Goto H, Sumiya K, Yoshida T, Tanaka K, Kohda Y. Stabilization of the Serum Lithium Concentration by Regulation of Sodium Chloride Intake: Case Report. Yakugaku Zasshi. 2016;136(3):517-21. doi: 10.1248/yakushi.15-00256.

Reference Type: BACKGROUND

PMID: 26935095 (View on PubMed)

Demers RG, Heninger GR. Sodium intake and lithium treatment in mania. Am J Psychiatry. 1971 Jul;128(1):100-4. doi: 10.1176/ajp.128.1.100. No abstract available.

Reference Type: BACKGROUND

PMID: 4949647 (View on PubMed)

Selvarajan S, Manohar H, Das S, Sakkarabani P, Kandasamy P. Lithium prophylaxis in early-onset Bipolar disorder: a descriptive study. Asian J Psychiatr. 2019 Aug;44:172-174. doi: 10.1016/j.ajp.2019.07.053. Epub 2019 Jul 30.

Reference Type: BACKGROUND

PMID: 31394485 (View on PubMed)

Tondo L, Vazquez GH, Baldessarini RJ. Depression and Mania in Bipolar Disorder. Curr Neuropharmacol. 2017 Apr;15(3):353-358. doi: 10.2174/1570159X14666160606210811.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21199968 (View on PubMed)

Murthy RS. National Mental Health Survey of India 2015-2016. Indian J Psychiatry. 2017 Jan-Mar;59(1):21-26. doi: 10.4103/psychiatry.IndianJPsychiatry_102_17. No abstract available.

Reference Type: BACKGROUND

PMID: 28529357 (View on PubMed)

Mandal S, Mamidipalli SS, Mukherjee B, Hara SKH. Perspectives, attitude, and practice of lithium prescription among psychiatrists in India. Indian J Psychiatry. 2019 Sep-Oct;61(5):451-456. doi: 10.4103/psychiatry.IndianJPsychiatry_451_18.

Reference Type: BACKGROUND

PMID: 31579157 (View on PubMed)

George S, Maiti R, Mishra BR, Jena M, Mohapatra D. Effect of regulated add-on sodium chloride intake on stabilization of serum lithium concentration in bipolar disorder: A randomized controlled trial. Bipolar Disord. 2023 Feb;25(1):66-75. doi: 10.1111/bdi.13276. Epub 2022 Nov 25.

Reference Type: DERIVED

PMID: 36409058 (View on PubMed)

Other Identifiers

IEC/AIIMS BBSR/PG Th/19-20/76

Identifier Type: -

Identifier Source: org_study_id