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

NCT04222816 | Completed Phase 4

• 1 other identifier: IEC/AIIMS BBSR/PG Th/19-20/76
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Affective Disorder

Keywords

Bipolar affective disorder; Lithium; Manic depressive psychosis; Sodium chloride

Outcome Measures

Primary Outcomes (1)

• Difference in percentage of bipolar patients showing fluctuation in serum lithium level

  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.

  12 weeks

Secondary Outcomes (6)

• Serum sodium

  12 weeks

• Serum Potassium

  12 weeks

• Serum creatinine

  12 weeks

• Serum aldosterone

  12 weeks

• ECG changes

  12 weeks

Study Arms (2)

Lithium carbonate

ACTIVE COMPARATOR

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

Drug: Lithium Carbonate

Add-on Sodium chloride

EXPERIMENTAL

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

Drug: Lithium Carbonate; Drug: Sodium chloride

Interventions

Lithium Carbonate DRUG

Lithium carbonate 800-900 mg orally daily for 12 weeks

Add-on Sodium chloride; Lithium carbonate

Sodium chloride DRUG

Sodium chloride 1gm daily per orally for 12 weeks

Add-on Sodium chloride

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

Aiims Bhubaneswar

Khordha, Odisha, 751019, India

Location

Related Publications (10)

• 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.

  PMID: 21383262 BACKGROUND

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

  PMID: 4189720 BACKGROUND

• 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.

  PMID: 26935095 BACKGROUND

• 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.

  PMID: 4949647 BACKGROUND

• 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.

  PMID: 31394485 BACKGROUND

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

  PMID: 28503106 BACKGROUND

• Kessler RC, Ormel J, Petukhova M, McLaughlin KA, Green JG, Russo LJ, Stein DJ, Zaslavsky AM, Aguilar-Gaxiola S, Alonso J, Andrade L, Benjet C, de Girolamo G, de Graaf R, Demyttenaere K, Fayyad J, Haro JM, Hu Cy, Karam A, Lee S, Lepine JP, Matchsinger H, Mihaescu-Pintia C, Posada-Villa J, Sagar R, Ustun TB. Development of lifetime comorbidity in the World Health Organization world mental health surveys. Arch Gen Psychiatry. 2011 Jan;68(1):90-100. doi: 10.1001/archgenpsychiatry.2010.180.

  PMID: 21199968 BACKGROUND

• 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.

  PMID: 28529357 BACKGROUND

• 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.

  PMID: 31579157 BACKGROUND

• 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.

  PMID: 36409058 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium Carbonate; Sodium Chloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• DEBASISH HOTA, DM

  PROFESSOR AND HEAD OF THE DEPARTMENT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Model Details: Randomized, open label, parallel group, active controlled clinical trial

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: January 16, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 7, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)