The effect of adding curcumin to sodium valproate in treatment of patients with bipolar disorder in the acute phase of mania: A randomized double-blind clinical trial

Abstract

BackgroundInflammatory processes play a role in the etiopathogenesis of bipolar disorder type 1. Full therapeutic responses are seldom seen and the ongoing inflammatory processes in the brain could lead to neuronal loss. Curcumin, a relatively safe herbal compound, has been shown to have anti-inflammatory effects. The present randomized double-blind clinical trial study aimed to investigate the effect of adding curcumin to the treatment regimen of BID.Materials and methodsThis randomized double-blind clinical trial was conducted on 78 patients diagnosed with BID according to the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria. The sample were divided into two groups. Patients in both groups received sodium valproate starting at a dose of 600 milligrams per day and administered up to 20 milligrams per kilogram per day or the highest dosage of the patient’s tolerance. Patients in the intervention group also received curcumin as nanomicelle in soft gelatin capsules 40 milligrams per day. The control group received placebo tablets with the same characteristics as the curcumin tablets. They were assessed by a psychiatrist using the Young Mania Rating Scale (YMRS), Mini-Mental State Examination (MMSE), Clinical Global Impression (CGI), and a medication side effect questionnaire at the beginning of the study, as well as in the first, second, and fourth weeks of the study.ResultsAmong the 78 patients chosen to participate in the project, 54 people completed the trial. No specific side effect was observed in the two groups. Both groups showed an increase in their MMSE scores compared to the beginning of the study (value of p < 0.001). Although this increase was not statistically different between the two groups (value of p = 0.68). The YMRS score of both groups decreased significantly by the end of the study (value of p < 0.001); however, this decrease was not significantly different between the two groups (value of p = 0.64). In addition, the two groups experienced a significant increase in their CGI scores throughout the study (value of p < 0.001), this increase however was not statistically different between the two groups (value of p = 0.88).ConclusionThe present study suggested that curcumin may not be a useful adjuvant agent in the management of patients with BID receiving sodium valproate as treatment.Clinical trial registration: Iranian Registry of Clinical Trials (IRCT), identifier IRCT2016102530504N1.

Curcumin as a Multifunctional Spice Ingredient against Mental Disorders in Humans: Current Clinical Studies and Bioavailability Concerns

“…However, a recent randomized control trial on humans with BD has revealed controversial results. Particularly, when nano-formulated curcumin was administrated in combination with different doses of sodium valproate to patients with BD in the maniac phase, no significant differences were observed between the interventional and the control group [53]. In this study, the enrolled patients in both groups received sodium valproate starting at a dose of 600 mg daily and administered up to 20 mg per Kg daily or the highest dosage of the patient's tolerance [53].…”

“…Particularly, when nano-formulated curcumin was administrated in combination with different doses of sodium valproate to patients with BD in the maniac phase, no significant differences were observed between the interventional and the control group [53]. In this study, the enrolled patients in both groups received sodium valproate starting at a dose of 600 mg daily and administered up to 20 mg per Kg daily or the highest dosage of the patient's tolerance [53]. Another study demonstrated significant improvements in depressive symptoms and anti-anxiety effects after curcumin and saffron supplementation [52].…”

Nanocurcumin supplementation improves pulmonary function in severe COPD patients: A randomized, double blind, and placebo‐controlled clinical trial

“…The intervention group received an oral nano-curcumin soft gel containing 80 mg curcumin as a nano micelle daily for 3 months, and the control group received an oral same dose placebo soft gel containing purified water, polysorbate 80, sorbitol 70, soy oil, methyl paraben, and propyl paraben daily for 3 months. Curcumin in this soft gel absorbed as equivalent to 1000 mg curcumin tablets (Akbarzadeh et al, 2023). This dose of curcumin was chosen due to no significant results from a clinical trial study on COPD subjects administered by 90 mg of Theracurmin (Funamoto et al, 2016).…”

Cognitive rehabilitation in bipolar spectrum disorder: A systematic review

“…The impairments observed could be attributed to neurodevelopmental factors like genetic vulnerability, inflammatory and metabolic factors, brain structural and functional variables as well as the progression of the illness, including the detrimental impact of recurring mood episodes and the long-term use of medication ( Tsapekos et al, 2019 ). Furthermore, numerous studies have established a strong relationship between neurocognitive deficits in BD and impairment in daily living activities, social interactions, and occupational functioning ( A Martinez-Aran et al, 2007 , Martínez-Arán et al, 2011 , Bonnin et al, 2013 , Akbarzadeh et al, 2023 ). Although pharmacological treatments improve clinical symptoms in BD, their effectiveness has been limited due to side effects ( Talaei et al, 2016 , Xu et al, 2020 ).…”