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NCT04222816
Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder
Phase 4 trial testing Lithium Carbonate in Bipolar Affective Disorder in 60 participants. Completed in 7 January 2022.
31 December 2021
Quick facts
| Lead sponsor | All India Institute of Medical Sciences, Bhubaneswar |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 16 January 2020 |
| Primary completion | 31 December 2021 |
| Estimated completion | 7 January 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- Lithium Carbonate (lithium carbonate) — full drug profile →
- Sodium chloride (Sodium Chloride) — full drug profile →
Conditions studied
- Bipolar Affective Disorder — all drugs for Bipolar Affective Disorder →
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Who can join
Adults 18 to 60, any sex, with Bipolar Affective Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of regulated add-on sodium chloride intake on stabilization of serum lithium concentration in bipolar disorder: A randomized controlled trial.
George S, Maiti R, Mishra BR, Jena M, et al · · 2023 · cited 4× · PMID 36409058 · DOI 10.1111/bdi.13276 -
Clinical and neuroendocrine correlates of childhood maltreatment history in adults with bipolar disorder
Donato S, Attianese N, Battipaglia M, Ceres R, et al · · 2023 -
Estimating the prevalence of alcohol abuse using phosphatidylethanol
Razvodovsky Y. · · 2023 -
Effect of Regulated Add-on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder: A Randomized Controlled Trial
Maiti R, George S, Mishra B, Jena M. · · 2023
Verify or expand the search:
- PubMed search for NCT04222816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04623398 — Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency) · Phase 3 · completed
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Other All India Institute of Medical Sciences, Bhubaneswar trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04222816 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by All India Institute of Medical Sciences, Bhubaneswar
- Last refreshed: 25 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04222816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing