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

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ClinicalTrials.gov Identifier: NCT04222816
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
RITUPARNA MAITI, 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.

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.


Condition or disease Intervention/treatment Phase
Bipolar Affective Disorder Drug: Lithium Carbonate Drug: Sodium chloride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open label, parallel group, active controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder: A Randomized Controlled Trial
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lithium carbonate
Lithium carbonate is prescribed 800-900 mg per day for 12 weeks.
Drug: Lithium Carbonate
Lithium carbonate 800-900 mg orally daily for 12 weeks

Experimental: 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.
Drug: Lithium Carbonate
Lithium carbonate 800-900 mg orally daily for 12 weeks

Drug: Sodium chloride
Sodium chloride 1gm daily per orally for 12 weeks




Primary Outcome Measures :
  1. Difference in percentage of bipolar patients showing fluctuation in serum lithium level [ Time Frame: 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 :
  1. Serum sodium [ Time Frame: 12 weeks ]
    Will be done by electrolyte analyzer.

  2. Serum Potassium [ Time Frame: 12 weeks ]
    Will be done by electrolyte analyzer.

  3. Serum creatinine [ Time Frame: 12 weeks ]
    Will be done by autoanalyser.

  4. Serum aldosterone [ Time Frame: 12 weeks ]
    Will be done by commercially available ELISA kit.

  5. ECG changes [ Time Frame: 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

  6. Serum Lithium [ Time Frame: 12 weeks ]
    Will be done by electrolyte analyzer.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222816


Contacts
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Contact: RITUPARNA MAITI, MD 9438884191 pharm_rituparna@aiimsbhubaneswar.edu.in
Contact: BISWA R MISHRA, MD 9438884220 brm1678@gmail.com

Locations
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India
Aiims Bhubaneswar Recruiting
Khorda, Orissa, India, 751019
Contact: RITUPARNA MAITI, MD    9438884191    pharm_rituparna@aiimsbhubaneswar.edu.in   
Contact: BISWA RANJAN MISHRA, MD    9438884220    brm1678@gmail.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Study Director: DEBASISH HOTA, DM PROFESSOR AND HEAD OF THE DEPARTMENT
Publications:

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Responsible Party: RITUPARNA MAITI, Additional Professor, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT04222816    
Other Study ID Numbers: IEC/AIIMS BBSR/PG Th/19-20/76
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar:
Bipolar affective disorder
Lithium
Manic depressive psychosis
Sodium chloride
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs