Safety, Tolerance, and Enhanced Efficacy of a Bioavailable Formulation of Curcumin With Fenugreek Dietary Fiber on Occupational Stress: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

Abstract:

:Drug delivery systems capable of delivering free (unconjugated) curcuminoids is of great therapeutic significance, since the absorption of bioactive and permeable form plays a key factor in mediating the efficacy of a substance which undergoes rapid biotransformation. Considering the recent understanding on the relatively high bioactivities and blood-brain-barrier permeability of free curcuminoids over their conjugated metabolites, the present human study investigated the safety, antioxidant efficacy, and bioavailability of CurQfen (curcumagalactomannoside [CGM]), a food-grade formulation of natural curcumin with fenugreek dietary fiber that has shown to possess improved blood-brain-barrier permeability and tissue distribution in rats. In this randomized double-blinded and placebo-controlled trial, 60 subjects experiencing occupational stress-related anxiety and fatigue were randomized to receive CGM, standard curcumin, and placebo for 30 days (500 mg twice daily). The study demonstrated the safety, tolerance, and enhanced efficacy of CGM in comparison with unformulated standard curcumin. A significant improvement in the quality of life (P < 0.05) with considerable reduction in stress (P < 0.001), anxiety (P < 0.001), and fatigue (P < 0.001) was observed among CGM-treated subjects as compared with the standard curcumin group, when monitored by SF-36, Perceived Stress Scale with 14 items, and Beck Anxiety Inventory scores. Improvement in the quality of life was further correlated with the significant enhancement in endogenous antioxidant markers (P < 0.01) and reduction in lipid peroxidation (P < 0.001). Further comparison of the free curcuminoids bioavailability after a single-dose (500 mg once per day) and repeated-dose (500 mg twice daily for 30 days) oral administration revealed enhanced absorption and improved pharmacokinetics of CGM upon both single- (30.7-fold) and repeated-dose (39.1-fold) administrations.

journal_name

J Clin Psychopharmacol

authors

Pandaran Sudheeran S,Jacob D,Natinga Mulakal J,Gopinathan Nair G,Maliakel A,Maliakel B,Kuttan R,Im K

doi

10.1097/JCP.0000000000000508

subject

Has Abstract

pub_date

2016-06-01 00:00:00

pages

236-43

issue

3

eissn

0271-0749

issn

1533-712X

journal_volume

36

pub_type

杂志文章,随机对照试验
  • Rating the raters: assessing the quality of Hamilton rating scale for depression clinical interviews in two industry-sponsored clinical drug trials.

    abstract:OBJECTIVE:The quality of clinical interviews conducted in industry-sponsored clinical drug trials is an important but frequently overlooked variable that may influence the outcome of a study. We evaluated the quality of Hamilton Rating Scale for Depression (HAM-D) clinical interviews performed at baseline in 2 similar ...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/01.jcp.0000194621.61868.7c

    authors: Engelhardt N,Feiger AD,Cogger KO,Sikich D,DeBrota DJ,Lipsitz JD,Kobak KA,Evans KR,Potter WZ

    更新日期:2006-02-01 00:00:00

  • Molindone hydrochloride: a review of laboratory and clinical findings.

    abstract::Molindone hydrochloride, a dihydroindolone neuroleptic, is structurally distinct from other classes of neuroleptics. Molindone exhibits many similarities to other neuroleptics, including dopamine receptor blockade, antipsychotic efficacy, and extrapyramidal side effects. Despite these similarities, molindone also has ...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,评审

    doi:

    authors: Owen RR Jr,Cole JO

    更新日期:1989-08-01 00:00:00

  • The Effect of Valproic Acid on Olanzapine Serum Concentration: A Study Including 2791 Patients Treated With Olanzapine Tablets or Long-Acting Injections.

    abstract:BACKGROUND:The combination of olanzapine and valproic acid (VPA) is regularly prescribed in the treatment of bipolar or schizoaffective disorders. The VPA has been shown to reduce olanzapine concentration, but the mechanism behind this interaction remains unknown. We aimed to investigate the effect of VPA on olanzapine...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0000000000001126

    authors: Tveito M,Smith RL,Høiseth G,Molden E

    更新日期:2019-11-01 00:00:00

  • Does nefazodone improve both depression and Parkinson disease? A pilot randomized trial.

    abstract::Some of the selective serotonin reuptake inhibitors (SSRI)-induced motor side effects are mediated by stimulating 5-HT2 receptors in the basal ganglia, probably because serotonin inhibits the subsequent neuronal dopamine release. We hypothesized that nefazodone, a serotonin 2 antagonist/reuptake inhibitor (SARI) that ...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/01.jcp.0000088908.24613.db

    authors: Avila A,Cardona X,Martin-Baranera M,Maho P,Sastre F,Bello J

    更新日期:2003-10-01 00:00:00

  • Exploring Nitrous Oxide as Treatment of Mood Disorders: Basic Concepts.

    abstract::Nitrous oxide (laughing gas) has shown early promise as a rapidly acting antidepressant in patients with treatment-resistant major depression and is currently investigated in several clinical trials. Because nitrous oxide is rarely administered outside operating rooms or dental practices, most psychiatrists are not fa...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,评审

    doi:10.1097/JCP.0000000000000837

    authors: Nagele P,Zorumski CF,Conway C

    更新日期:2018-04-01 00:00:00

  • Effect of fluvoxamine on panic disorder.

    abstract::Several reports suggest that selective serotonin reuptake blockers are helpful in the treatment of panic disorder. The aim of the study was to compare fluvoxamine with placebo in 50 panic disorder patients by using an 8-week, double-blind, parallel-groups design. Weekly assessment included a panic attack diary (freque...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Hoehn-Saric R,McLeod DR,Hipsley PA

    更新日期:1993-10-01 00:00:00

  • Sexual dysfunction in first-episode schizophrenia patients: results from European First Episode Schizophrenia Trial.

    abstract::Sexual dysfunctions (SDs) occur frequently in schizophrenia patients and have a huge impact on quality of life and compliance. They are often associated with antipsychotic medication. Nicotine consumption, negative or depressive symptoms, and physical illness are also discussed as contributing factors. Data on SD in f...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/JCP.0b013e3182199bcc

    authors: Malik P,Kemmler G,Hummer M,Riecher-Roessler A,Kahn RS,Fleischhacker WW,EUFEST Study Group.

    更新日期:2011-06-01 00:00:00

  • Tiaspirone in schizophrenia.

    abstract::It was predicted that tiaspirone, a novel compound, would benefit schizophrenic patients since in animal experiments it is a potent dopamine blocker. Following a placebo washout period of 1 to 2 weeks, 14 patients were treated for 28 days with the drug in a single-blind, dose ranging trial. GAS, NOSIE, and BPRS scores...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:

    authors: Moore NC,Meyendorff E,Yeragani V,LeWitt PA,Gershon S

    更新日期:1987-04-01 00:00:00

  • Influence of dose, cigarette smoking, age, sex, and metabolic activity on plasma clozapine concentrations: a predictive model and nomograms to aid clozapine dose adjustment and to assess compliance in individual patients.

    abstract::The measurement of plasma clozapine concentrations is useful in assessing compliance, optimizing therapy, and minimizing toxicity. We measured plasma clozapine and norclozapine (N-desmethylclozapine) concentrations in samples from 3782 patients (2648 male, 1127 female). No clozapine was detected in 291 samples (227 pa...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/01.jcp.0000106221.36344.4d

    authors: Rostami-Hodjegan A,Amin AM,Spencer EP,Lennard MS,Tucker GT,Flanagan RJ

    更新日期:2004-02-01 00:00:00

  • Lack of efficacy of low doses of quetiapine addition in refractory obsessive-compulsive disorder.

    abstract:BACKGROUND:Some studies have shown that low dose of neuroleptic addition to ongoing antiobsessive treatment might be effective in treatment resistant obsessive-compulsive disorder (OCD). The primary purpose of this study was to evaluate the efficacy of low-dose quetiapine in clomipramine and serotonin reuptake inhibito...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/01.jcp.0000088900.24613.f2

    authors: Sevincok L,Topuz A

    更新日期:2003-10-01 00:00:00

  • Polymorphic variations in GSTM1, GSTT1, PgP, CYP2D6, CYP3A5, and dopamine D2 and D3 receptors and their association with tardive dyskinesia in severe mental illness.

    abstract::This study tested the association between tardive dyskinesia (TD) and polymorphic variations in (a) 2 cytochrome P450 (CYP) genes (CYP2D6 or CYP3A5), (b) 2 DRD2 variants (Ser311Cys and -141C Ins/del) and the Ser9Gly DRD3 variants, (c) 2 glutathione S-transferases (GSTT1 and GSTM1), and (d) variations in the PgP gene, ...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/01.jcp.0000177546.34799.af

    authors: de Leon J,Susce MT,Pan RM,Koch WH,Wedlund PJ

    更新日期:2005-10-01 00:00:00

  • Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine.

    abstract:CONTEXT:Major depressive disorder causes significant morbidity and mortality. Current therapies fail to fully treat both emotional and physical symptoms of major depressive disorder. OBJECTIVE:To evaluate duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, on improvement of emotional and painful phy...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1097/01.jcp.0000132448.65972.d9

    authors: Goldstein DJ,Lu Y,Detke MJ,Wiltse C,Mallinckrodt C,Demitrack MA

    更新日期:2004-08-01 00:00:00

  • Alprazolam treatment of postcoronary bypass anxiety and depression.

    abstract::The effectiveness of alprazolam in treating symptoms of anxiety and depression in 60 patients undergoing coronary bypass surgery was assessed in a double-blind, placebo-controlled study. The results indicate that alprazolam treatment for anxiety following coronary bypass surgery, particularly symptoms occurring in the...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Freeman AM 3rd,Fleece L,Folks DG,Sokol RS,Hall KR,Pacifico AD,McGiffin DC,Kirklin JK,Zorn GL,Karp RB

    更新日期:1986-02-01 00:00:00

  • Open-label pilot study of modafinil for methamphetamine dependence.

    abstract::Methamphetamine has become a major public health issue globally, particularly in the United States. Despite this, no effective pharmacotherapy for methamphetamine abuse has been developed to date. This 6-week, open-label pilot clinical trial examined the safety and tolerability of modafinil up to 400 mg/d in 8 methamp...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/JCP.0b013e3181b591e0

    authors: McGaugh J,Mancino MJ,Feldman Z,Chopra MP,Gentry WB,Cargile C,Oliveto A

    更新日期:2009-10-01 00:00:00

  • Aripiprazole in schizophrenia with cocaine dependence: a pilot study.

    abstract::The debilitation of schizophrenia (SCHZ) worsens markedly with comorbid cocaine dependence (CD) and alcohol abuse. To date, no medications have conclusively demonstrated effects against both SCHZ and CD (SCHZ + CD) simultaneously. Because of its dopamine-modulating properties, we hypothesized that aripiprazole would a...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/01.jcp.0000169419.38899.5b

    authors: Beresford TP,Clapp L,Martin B,Wiberg JL,Alfers J,Beresford HF

    更新日期:2005-08-01 00:00:00

  • Multiple-dose pharmacokinetics of clozapine in patients with chronic schizophrenia.

    abstract::The pharmacokinetic parameters of clozapine and its two main metabolites, N-desmethylclozapine (norclozapine, active metabolite) and clozapine N-oxide, were evaluated, after oral administration, in 19 patients with chronic schizophrenia. Plasma and red blood cell (RBC) drug concentrations were determined by high-perfo...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/00004714-199812000-00010

    authors: Guitton C,Abbar M,Kinowski JM,Chabrand P,Bressolle F

    更新日期:1998-12-01 00:00:00

  • Exposure to anticholinergic and sedative drugs, risk of falls, and mortality: an elderly inpatient, multicenter cohort.

    abstract::This study aimed to assess whether exposure to anticholinergic and sedative medications and its evolution was associated with increased risk of in-hospital falls and all-cause mortality. Furthermore, results were compared with 2 definitions of drug burden index (DBI) against the outcomes.This observational, multicentr...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究

    doi:10.1097/JCP.0000000000000195

    authors: Dauphinot V,Faure R,Omrani S,Goutelle S,Bourguignon L,Krolak-Salmon P,Mouchoux C

    更新日期:2014-10-01 00:00:00

  • α7 Nicotinic Acetylcholine Receptor: A Potential Target in Treating Cognitive Decline in Schizophrenia.

    abstract:PURPOSE:The aim of this article is to review the recent trials of α7 nicotinic acetylcholine receptor (α7 nAChR) agonists and positive allosteric modulators (PAMs) on the treatment of cognitive decline in schizophrenia. α7 Nicotinic acetylcholine receptor abnormalities in schizophrenia and clinical implications of α7 n...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,评审

    doi:10.1097/JCP.0000000000000859

    authors: Jones C

    更新日期:2018-06-01 00:00:00

  • Methamphetamine self-administration in humans during D-amphetamine maintenance.

    abstract::Agonist replacement may be a viable treatment approach for managing stimulant use disorders. This study sought to determine the effects of D-amphetamine maintenance on methamphetamine self-administration in stimulant using human participants. We predicted that D-amphetamine maintenance would reduce methamphetamine sel...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0000000000000207

    authors: Pike E,Stoops WW,Hays LR,Glaser PE,Rush CR

    更新日期:2014-12-01 00:00:00

  • Double-Blind, Randomized, Placebo-Controlled Trial of Metoclopramide for Hypersalivation Associated With Clozapine.

    abstract::Hypersalivation is a frequent, disturbing, and uncomfortable adverse effect of clozapine therapy that frequently leads to noncompliance. The aim of this study was to examine the efficacy of metoclopramide (dopamine D2 antagonist, antiemetic medication) as an option for management of hypersalivation associated with clo...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/JCP.0000000000000493

    authors: Kreinin A,Miodownik C,Mirkin V,Gaiduk Y,Yankovsky Y,Bersudsky Y,Lerner PP,Bergman J,Lerner V

    更新日期:2016-06-01 00:00:00

  • Self-reported cravings for heroin and cocaine during maintenance treatment with slow-release oral morphine compared with methadone: a randomized, crossover clinical trial.

    abstract:OBJECTIVE:Craving, an urge or increased desire to take a drug, is part of a cluster of behavioral, cognitive, and physiological phenomena that can develop after substance use. Self-reported cravings for heroin and cocaine are compared in opioid dependent patients while receiving maintenance treatment with slow-release ...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/JCP.0000000000000288

    authors: Falcato L,Beck T,Reimer J,Verthein U

    更新日期:2015-04-01 00:00:00

  • Alprazolam in the treatment of obsessive symptoms.

    abstract::Four patients with obsessive-compulsive disorder (DSM-III and RDC) were treated in an open trial with alprazolam. Moderate to marked improvement was noted in the degree of obsessionality, anxiety with motor tension, and secondary affective changes. The mixed anxiolytic-antidepressant properties of alprazolam are theor...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:

    authors: Tollefson G

    更新日期:1985-02-01 00:00:00

  • The effect of 2 different single injections of high dose of vitamin D on improving the depression in depressed patients with vitamin D deficiency: a randomized clinical trial.

    abstract::The correlation between vitamin D deficiency and depression has recently been put forward and resulted in controversial findings. The present study was conducted to find out the effect of 2 single injections of 150,000 and 300,000 IU of vitamin D on improving the depression in depressed patients with vitamin D deficie...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/JCP.0b013e31828f619a

    authors: Mozaffari-Khosravi H,Nabizade L,Yassini-Ardakani SM,Hadinedoushan H,Barzegar K

    更新日期:2013-06-01 00:00:00

  • Monthly Extended-Release Risperidone (RBP-7000) in the Treatment of Schizophrenia: Results From the Phase 3 Program.

    abstract:PURPOSE/BACKGROUND:The Phase 3 program for RBP-7000, a once-monthly subcutaneous (SC) extended-release risperidone formulation approved for treatment of schizophrenia, consisted of a double-blind placebo-controlled trial (previously reported) and a 52-week open-label study of monthly RBP-7000 120 mg. The primary object...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究

    doi:10.1097/JCP.0000000000001076

    authors: Andorn A,Graham J,Csernansky J,Newcomer JW,Shinde S,Muma G,Heidbreder C,Fava M

    更新日期:2019-09-01 00:00:00

  • The association of genetic polymorphisms in the κ-opioid receptor 1 gene with body weight, alcohol use, and withdrawal symptoms in patients with methadone maintenance.

    abstract::Methadone is a synthetic opioid that binds to the κ-opioid receptor with a low affinity. This study tested the hypotheses that the genetic polymorphisms in the κ-opioid receptor 1 (OPRK1) gene region are associated with methadone treatment responses in a Taiwan methadone maintenance treatment (MMT) cohort. Seventeen s...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/JCP.0000000000000082

    authors: Wang SC,Tsou HH,Chung RH,Chang YS,Fang CP,Chen CH,Ho IK,Kuo HW,Liu SC,Shih YH,Wu HY,Huang BH,Lin KM,Chen AC,Hsiao CF,Liu YL

    更新日期:2014-04-01 00:00:00

  • Aripiprazole and dehydroaripiprazole plasma concentrations and clinical responses in patients with schizophrenia.

    abstract::Aripiprazole is widely used to treat schizophrenia. Plasma levels of aripiprazole and its active metabolite dehydroaripiprazole and their clinical responses in patients were explored. Forty-five (male/female: 19/26) patients with schizophrenia were treated with aripiprazole after a washout period of at least 3 days. T...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/JCP.0b013e3182356255

    authors: Lin SK,Chen CK,Liu YL

    更新日期:2011-12-01 00:00:00

  • Cognitive effects of a single dose of atypical antipsychotics in healthy volunteers compared with placebo or haloperidol.

    abstract::Cognitive dysfunction in patients with schizophrenia is a strong correlate of poor outcome than any other symptom domain. To have greater knowledge about the effects of antipsychotics on cognitive function, subjects of this study were healthy volunteers who had no confounding variables typically found in patients with...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/JCP.0b013e318272d10c

    authors: Chung YC,Park TW,Yang JC,Huang GB,Zhao T,Oh KY,Kim MG

    更新日期:2012-12-01 00:00:00

  • Assessment of the prescription of antidepressant drugs in elderly nursing home patients: a clinical and laboratory follow-up investigation.

    abstract::The aim of the study was to investigate the use of antidepressant drugs among elderly people in nursing homes. Elderly residents who where found to have been prescribed at least one antidepressant drug according to the specific medication dispensing system were identified in 8 nursing homes in the county of Ostergötla...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究

    doi:10.1097/JCP.0b013e31817d79eb

    authors: Chermá MD,Löfgren UB,Almkvist G,Hallert C,Bengtsson F

    更新日期:2008-08-01 00:00:00

  • Psychotropic drugs associated with corrected QT interval prolongation.

    abstract:AIMS:To study whether listed putative corrected QT (QTc)-prolonging psychotropic drugs indeed prolong the QTc interval under everyday circumstances and to evaluate whether this is a class effect or an individual drug effect, we conducted a prospective population-based cohort study. METHODS:This study was conducted as ...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0b013e318191c6a8

    authors: van Noord C,Straus SM,Sturkenboom MC,Hofman A,Aarnoudse AJ,Bagnardi V,Kors JA,Newton-Cheh C,Witteman JC,Stricker BH

    更新日期:2009-02-01 00:00:00

  • A thorough QTc study of 3 doses of iloperidone including metabolic inhibition via CYP2D6 and/or CYP3A4 and a comparison to quetiapine and ziprasidone.

    abstract::The potential for iloperidone, a D2/5-HT2A antipsychotic, to affect the heart rate-corrected QT interval (QTc) was assessed in the absence and presence of metabolic inhibitors in a randomized, open-label, multicenter study. QT interval prolongation by medications, including both conventional and atypical antipsychotic...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/JCP.0b013e31827c0314

    authors: Potkin SG,Preskorn S,Hochfeld M,Meng X

    更新日期:2013-02-01 00:00:00