kynurenine has been researched along with Depression, Endogenous in 46 studies
Kynurenine: A metabolite of the essential amino acid tryptophan metabolized via the tryptophan-kynurenine pathway.
kynurenine : A ketone that is alanine in which one of the methyl hydrogens is substituted by a 2-aminobenzoyl group.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Abnormalities of the kynurenine (KYN) pathway may be implicated in the pathophysiology of depression." | 8.98 | Kynurenine pathway in depression: A systematic review and meta-analysis. ( Graff-Guerrero, A; Iwata, Y; Kubo, K; Mimura, M; Miyazaki, T; Moriguchi, S; Nakajima, S; Noda, Y; Ogyu, K; Omura, Y; Plitman, E; Tarumi, R; Tsugawa, S; Uchida, H; Wada, M, 2018) |
| "The aim of this paper is to elucidate the role of oxidative and nitrosative stress as well as the tryptophan catabolites pathway in the development of depression and the mechanism of action of antidepressant drugs, based on the available literature." | 8.95 | Oxidative and Nitrosative Stress as Well as the Tryptophan Catabolites Pathway in Depressive Disorders. ( Czarny, P; Galecki, P; Sliwinski, T; Wigner, P, 2017) |
| " The aim of this article is to present results of contemporary research studies over mutual connections between social cognition, cognitive processes and inflammatory factors significant for the aetiology of recurrent depressive disorders, with particular reference to the role of kynurenine pathways." | 8.93 | Cognition and Emotions in Recurrent Depressive Disorders - The Role of Inflammation and the Kynurenine Pathway. ( Galecki, P; Talarowska, M, 2016) |
| "In both cohorts, inflammation as measured by higher levels of CRP, sVCAM1 and sICAM1 was associated with kynurenine/tryptophan ratio and thus enhanced tryptophan breakdown (beta: 0." | 7.88 | Psychosocial stress and inflammation driving tryptophan breakdown in children and adolescents: A cross-sectional analysis of two cohorts. ( Carvalho, LA; Clarke, G; Díaz, LE; Gómez-Martínez, S; Marcos, A; Michels, N; Olavarria-Ramirez, L; Widhalm, K, 2018) |
| "We evaluated 101 patients with chronic hepatitis C treated with PEG-IFN-α2a, and 40 controls, so as to determine the activation of indolamine 2,3-dioxygenase (IDO) and tryptophan (TRP) and their metabolites' concentrations/levels: kynurenine (KYN), kynurenic acid (KYNA) and anthranilic acid (AA)." | 7.88 | Alterations in the metabolism of tryptophan in patients with chronic hepatitis C six months after pegylated interferon-α 2a treatment. ( Inglot, M; Laskus, T; Malyszczak, K; Pawlak, D; Pawlowski, T; Radkowski, M; Zalewska, M, 2018) |
| "Kynurenines, the major degradative products of the essential amino acid tryptophan, may play critical roles in the pathophysiology of depressive disorders." | 7.88 | Exercise Your Kynurenines to Fight Depression. ( Notarangelo, FM; Pocivavsek, A; Schwarcz, R, 2018) |
| "Ketamine has rapid antidepressant effects on treatment-resistant depression, but the biological mechanism underpinning this effect is less clear." | 7.88 | Antidepressant effect of repeated ketamine administration on kynurenine pathway metabolites in patients with unipolar and bipolar depression. ( Chen, L; Li, H; Li, M; Liu, W; Ning, Y; Wang, C; Zhan, Y; Zheng, W; Zhou, Y, 2018) |
| "Depressive disorders are the most frequently diagnosed mental disorder." | 6.58 | [The importance of the kynurenine pathway in depressive disorders]. ( Filip, M; Gałecki, P; Jasionowska, J; Talarowska, M, 2018) |
| "In the patients' group with endogenous depression, plasma kynurenine was significantly lower than in controls but did not agree with the depression gravity." | 5.28 | [Plasma kynurenine levels and the dexamethasone test in patients with endogenous anxiety disorders and depression]. ( Orlikov, AB; Prakh'e, IB; Ryzhov, IV, 1990) |
| "Abnormalities of the kynurenine (KYN) pathway may be implicated in the pathophysiology of depression." | 4.98 | Kynurenine pathway in depression: A systematic review and meta-analysis. ( Graff-Guerrero, A; Iwata, Y; Kubo, K; Mimura, M; Miyazaki, T; Moriguchi, S; Nakajima, S; Noda, Y; Ogyu, K; Omura, Y; Plitman, E; Tarumi, R; Tsugawa, S; Uchida, H; Wada, M, 2018) |
| "The aim of this paper is to elucidate the role of oxidative and nitrosative stress as well as the tryptophan catabolites pathway in the development of depression and the mechanism of action of antidepressant drugs, based on the available literature." | 4.95 | Oxidative and Nitrosative Stress as Well as the Tryptophan Catabolites Pathway in Depressive Disorders. ( Czarny, P; Galecki, P; Sliwinski, T; Wigner, P, 2017) |
| " The aim of this article is to present results of contemporary research studies over mutual connections between social cognition, cognitive processes and inflammatory factors significant for the aetiology of recurrent depressive disorders, with particular reference to the role of kynurenine pathways." | 4.93 | Cognition and Emotions in Recurrent Depressive Disorders - The Role of Inflammation and the Kynurenine Pathway. ( Galecki, P; Talarowska, M, 2016) |
| " The aim of the present study was to analyze gut microbiota composition in bipolar disorder (BD) and its relation to inflammation, serum lipids, oxidative stress, tryptophan (TRP)/kynurenine (KYN) levels, anthropometric measurements and parameters of metabolic syndrome." | 3.91 | A step ahead: Exploring the gut microbiota in inpatients with bipolar disorder during a depressive episode. ( Bengesser, S; Birner, A; Dalkner, N; Fellendorf, F; Gorkiewicz, G; Halwachs, B; Holl, AK; Holzer, P; Kapfhammer, HP; Kashofer, K; Moll, N; Mörkl, S; Painold, A; Platzer, M; Queissner, R; Reininghaus, EZ; Schütze, G; Schwarz, MJ, 2019) |
| " In the present study, the induction of depression via the kynurenine pathway by different redox states of HMGB1 was investigated in vivo and in vitro." | 3.91 | Fr‑HMGB1 and ds‑HMGB1 activate the kynurenine pathway via different mechanisms in association with depressive‑like behavior. ( Jiang, CL; Li, JM; Lian, YJ; Liu, LL; Su, WJ; Wang, B; Wang, YX, 2019) |
| " Here, the potential mechanism of HMGB1 mediating chronic-stress-induced depression through the kynurenine pathway (KP) was further explored both in vivo and in vitro." | 3.88 | HMGB1 mediates depressive behavior induced by chronic stress through activating the kynurenine pathway. ( Dong, X; Gong, H; Jiang, CL; Lian, YJ; Liu, LL; Peng, W; Su, WJ; Wang, B; Wang, YX; Zhang, T, 2018) |
| "In both cohorts, inflammation as measured by higher levels of CRP, sVCAM1 and sICAM1 was associated with kynurenine/tryptophan ratio and thus enhanced tryptophan breakdown (beta: 0." | 3.88 | Psychosocial stress and inflammation driving tryptophan breakdown in children and adolescents: A cross-sectional analysis of two cohorts. ( Carvalho, LA; Clarke, G; Díaz, LE; Gómez-Martínez, S; Marcos, A; Michels, N; Olavarria-Ramirez, L; Widhalm, K, 2018) |
| "We evaluated 101 patients with chronic hepatitis C treated with PEG-IFN-α2a, and 40 controls, so as to determine the activation of indolamine 2,3-dioxygenase (IDO) and tryptophan (TRP) and their metabolites' concentrations/levels: kynurenine (KYN), kynurenic acid (KYNA) and anthranilic acid (AA)." | 3.88 | Alterations in the metabolism of tryptophan in patients with chronic hepatitis C six months after pegylated interferon-α 2a treatment. ( Inglot, M; Laskus, T; Malyszczak, K; Pawlak, D; Pawlowski, T; Radkowski, M; Zalewska, M, 2018) |
| "Kynurenines, the major degradative products of the essential amino acid tryptophan, may play critical roles in the pathophysiology of depressive disorders." | 3.88 | Exercise Your Kynurenines to Fight Depression. ( Notarangelo, FM; Pocivavsek, A; Schwarcz, R, 2018) |
| "Ketamine has rapid antidepressant effects on treatment-resistant depression, but the biological mechanism underpinning this effect is less clear." | 3.88 | Antidepressant effect of repeated ketamine administration on kynurenine pathway metabolites in patients with unipolar and bipolar depression. ( Chen, L; Li, H; Li, M; Liu, W; Ning, Y; Wang, C; Zhan, Y; Zheng, W; Zhou, Y, 2018) |
| "Depressive disorders are the most frequently diagnosed mental disorder." | 2.58 | [The importance of the kynurenine pathway in depressive disorders]. ( Filip, M; Gałecki, P; Jasionowska, J; Talarowska, M, 2018) |
| "Quinolinic acid was increased and kynurenic acid decreased over time in suicidal patients versus healthy controls." | 1.42 | A role for inflammatory metabolites as modulators of the glutamate N-methyl-D-aspartate receptor in depression and suicidality. ( Bay-Richter, C; Brundin, L; Erhardt, S; Guillemin, GJ; Lim, CK; Linderholm, KR; Samuelsson, M; Träskman-Bendz, L, 2015) |
| "Subsequently, endogenous depression may be caused by TPH1 dysfunction combined with compensatory TPH2 activation." | 1.40 | Etiological classification of depression based on the enzymes of tryptophan metabolism. ( Fukuda, K, 2014) |
| "Although adolescent major depressive disorder (MDD) is acknowledged to be a heterogeneous disorder, no studies have reported on biological correlates of its clinical subgroups." | 1.36 | The possible role of the kynurenine pathway in adolescent depression with melancholic features. ( Alonso, CM; Babb, JS; Gabbay, V; Guttman, LE; Hirsch, GS; Katz, Y; Klein, RG; Liebes, L; Mendoza, S, 2010) |
| "In the patients' group with endogenous depression, plasma kynurenine was significantly lower than in controls but did not agree with the depression gravity." | 1.28 | [Plasma kynurenine levels and the dexamethasone test in patients with endogenous anxiety disorders and depression]. ( Orlikov, AB; Prakh'e, IB; Ryzhov, IV, 1990) |
| "Mestranol was less potent than ethinylestradiol on the effect on plasma tyrosine." | 1.26 | Effect of oral contraceptives on tryptophan and tyrosine availability: evidence for a possible contribution to mental depression. ( Møller, SE, 1981) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 2 (4.35) | 18.7374 |
| 1990's | 2 (4.35) | 18.2507 |
| 2000's | 6 (13.04) | 29.6817 |
| 2010's | 36 (78.26) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Wang, B | 3 |
| Lian, YJ | 3 |
| Su, WJ | 3 |
| Peng, W | 2 |
| Dong, X | 2 |
| Liu, LL | 3 |
| Gong, H | 2 |
| Zhang, T | 2 |
| Jiang, CL | 3 |
| Wang, YX | 3 |
| Wigner, P | 1 |
| Czarny, P | 1 |
| Galecki, P | 2 |
| Sliwinski, T | 1 |
| Li, JS | 1 |
| Ogyu, K | 1 |
| Kubo, K | 1 |
| Noda, Y | 1 |
| Iwata, Y | 1 |
| Tsugawa, S | 1 |
| Omura, Y | 1 |
| Wada, M | 1 |
| Tarumi, R | 1 |
| Plitman, E | 1 |
| Moriguchi, S | 1 |
| Miyazaki, T | 1 |
| Uchida, H | 1 |
| Graff-Guerrero, A | 1 |
| Mimura, M | 1 |
| Nakajima, S | 1 |
| Michels, N | 1 |
| Clarke, G | 1 |
| Olavarria-Ramirez, L | 1 |
| Gómez-Martínez, S | 1 |
| Díaz, LE | 1 |
| Marcos, A | 1 |
| Widhalm, K | 1 |
| Carvalho, LA | 1 |
| Walker, AK | 2 |
| Wing, EE | 1 |
| Banks, WA | 1 |
| Dantzer, R | 3 |
| Pawlowski, T | 1 |
| Malyszczak, K | 1 |
| Inglot, M | 1 |
| Zalewska, M | 1 |
| Radkowski, M | 1 |
| Laskus, T | 1 |
| Pawlak, D | 1 |
| Painold, A | 1 |
| Mörkl, S | 1 |
| Kashofer, K | 1 |
| Halwachs, B | 1 |
| Dalkner, N | 1 |
| Bengesser, S | 1 |
| Birner, A | 1 |
| Fellendorf, F | 1 |
| Platzer, M | 1 |
| Queissner, R | 1 |
| Schütze, G | 1 |
| Schwarz, MJ | 3 |
| Moll, N | 1 |
| Holzer, P | 1 |
| Holl, AK | 1 |
| Kapfhammer, HP | 2 |
| Gorkiewicz, G | 1 |
| Reininghaus, EZ | 1 |
| Notarangelo, FM | 2 |
| Pocivavsek, A | 2 |
| Schwarcz, R | 2 |
| Takada, A | 1 |
| Shimizu, F | 1 |
| Takao, T | 1 |
| Zhou, Y | 1 |
| Zheng, W | 1 |
| Liu, W | 1 |
| Wang, C | 1 |
| Zhan, Y | 1 |
| Li, H | 1 |
| Chen, L | 1 |
| Li, M | 1 |
| Ning, Y | 1 |
| Jasionowska, J | 1 |
| Filip, M | 1 |
| Talarowska, M | 2 |
| Gałecki, P | 1 |
| Harkin, A | 3 |
| McLoughlin, DM | 1 |
| Koo, YS | 1 |
| Kim, H | 1 |
| Park, JH | 1 |
| Kim, MJ | 1 |
| Shin, YI | 1 |
| Choi, BT | 1 |
| Lee, SY | 1 |
| Shin, HK | 1 |
| Hüfner, K | 1 |
| Fuchs, D | 1 |
| Blauth, M | 1 |
| Sperner-Unterweger, B | 1 |
| Zimmer, P | 1 |
| Joisten, N | 1 |
| Schenk, A | 1 |
| Bloch, W | 1 |
| Li, JM | 1 |
| Baranyi, A | 1 |
| Meinitzer, A | 1 |
| Stepan, A | 1 |
| Putz-Bankuti, C | 1 |
| Breitenecker, RJ | 1 |
| Stauber, R | 1 |
| Rothenhäusler, HB | 1 |
| Gibney, SM | 1 |
| Fagan, EM | 1 |
| Waldron, AM | 1 |
| O'Byrne, J | 1 |
| Connor, TJ | 1 |
| Bay-Richter, C | 1 |
| Linderholm, KR | 1 |
| Lim, CK | 1 |
| Samuelsson, M | 1 |
| Träskman-Bendz, L | 1 |
| Guillemin, GJ | 1 |
| Erhardt, S | 2 |
| Brundin, L | 1 |
| Fukuda, K | 1 |
| Guloksuz, S | 1 |
| Arts, B | 1 |
| Walter, S | 1 |
| Drukker, M | 1 |
| Rodriguez, L | 1 |
| Myint, AM | 3 |
| Ponds, R | 1 |
| van Os, J | 1 |
| Kenis, G | 1 |
| Rutten, BP | 1 |
| Mahmoud, ME | 1 |
| Ihara, F | 1 |
| Fereig, RM | 1 |
| Nishimura, M | 1 |
| Nishikawa, Y | 1 |
| Zepf, FD | 1 |
| Stewart, RM | 1 |
| Guillemin, G | 1 |
| Ruas, JL | 1 |
| Clark, SM | 1 |
| Nicholson, JD | 1 |
| Langenberg, P | 1 |
| McMahon, RP | 1 |
| Kleinman, JE | 1 |
| Hyde, TM | 1 |
| Stiller, J | 1 |
| Postolache, TT | 1 |
| Tonelli, LH | 1 |
| Eskelund, A | 1 |
| Budac, DP | 1 |
| Sanchez, C | 1 |
| Elfving, B | 1 |
| Wegener, G | 1 |
| Liu, XC | 1 |
| Goiny, M | 1 |
| Engberg, G | 1 |
| Mathé, AA | 1 |
| Marin, IA | 1 |
| Goertz, JE | 1 |
| Ren, T | 1 |
| Rich, SS | 1 |
| Onengut-Gumuscu, S | 1 |
| Farber, E | 1 |
| Wu, M | 1 |
| Overall, CC | 1 |
| Kipnis, J | 1 |
| Gaultier, A | 1 |
| McNally, L | 1 |
| Bhagwagar, Z | 1 |
| Hannestad, J | 1 |
| Vignau, J | 1 |
| Costisella, O | 1 |
| Canva, V | 1 |
| Imbenotte, M | 1 |
| Duhamel, A | 1 |
| Lhermitte, M | 1 |
| Müller, N | 2 |
| Gabbay, V | 1 |
| Klein, RG | 1 |
| Katz, Y | 1 |
| Mendoza, S | 1 |
| Guttman, LE | 1 |
| Alonso, CM | 1 |
| Babb, JS | 1 |
| Hirsch, GS | 1 |
| Liebes, L | 1 |
| Chopra, K | 1 |
| Kumar, B | 1 |
| Kuhad, A | 1 |
| Kim, YK | 1 |
| Verkerk, R | 2 |
| Scharpé, S | 1 |
| Steinbusch, H | 1 |
| Leonard, B | 1 |
| Hafizi, S | 1 |
| Favaron, E | 1 |
| Maes, M | 2 |
| Mihaylova, I | 1 |
| Ruyter, MD | 1 |
| Kubera, M | 1 |
| Bosmans, E | 1 |
| Møller, SE | 2 |
| Kirk, L | 1 |
| Honoré, P | 1 |
| Orlikov, AB | 2 |
| Prakhye, IB | 1 |
| Ryzov, IV | 1 |
| Bonaccorso, S | 1 |
| Marino, V | 1 |
| Puzella, A | 1 |
| Pasquini, M | 1 |
| Biondi, M | 1 |
| Artini, M | 1 |
| Almerighi, C | 1 |
| Meltzer, H | 1 |
| Prakh'e, IB | 1 |
| Ryzhov, IV | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation[NCT05866575] | 136 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting | |||
| Pilot Study Aimed to Determine the Optimal Design for the UCLA/Danone Probiotic Intervention Study Related to Stress[NCT05026333] | 100 participants (Actual) | Interventional | 2021-06-25 | Completed | |||
| "Proof-of-Concept Stress & Anxiety Dampening Effects of Lpc-37"[NCT03494725] | 120 participants (Actual) | Interventional | 2018-04-10 | Completed | |||
| A Randomized Controlled Trial of Adjunctive Siltuximab in Schizophrenia[NCT02796859] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting | ||
| An Open-Label Trial of Tocilizumab in Schizophrenia[NCT01696929] | Phase 1 | 8 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| Kynurenine Pathway Metabolites as Novel Translational Biological Markers of Irritable Bowel Syndrome: Relationship to Gastrointestinal Function, Cognition and Co-morbid Depression[NCT01304355] | 85 participants (Anticipated) | Observational | 2011-01-31 | Recruiting | |||
| Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes: Role of Inflammation, Kynurenine Pathway, and Structural and Functional Brain Connectivity as Biomarkers[NCT03580967] | Phase 4 | 0 participants (Actual) | Interventional | 2019-07-01 | Withdrawn (stopped due to COVID-19 Pandemic interfered with Pt recruitment) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Efficacy of the intake of Lpc-37 on reduction of the increase of the diastolic BP in response to the TSST compared to placebo. (NCT03494725)
Timeframe: 3 minutes before the TSST and 1 minute after the TSST after 5 weeks of study product intake
| Intervention | mmHg (Mean) | |
|---|---|---|
| Pre-TSST -3min | Post-TSST +1min | |
| Lpc-37 | 79.13 | 90.38 |
| Placebo | 78.41 | 88.36 |
"Efficacy of the intake of Lpc-37 on the increase of mood scale scores over the course of the treatment~Measured with a daily online diary. Mood was rated by participants on an 11-point scale (0-10; very bad to very well) and monitored through the washout phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a better mood. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one average value for each week and participant. Values reflect summary measures for mood ratings on a scale from 0 to 10 for the averaged ratings per participant and week." (NCT03494725)
Timeframe: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
| Intervention | score (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (run-in) | Week 2 (run-in) | Week 3 (treatment) | Week 4 (treatment) | Week 5 (treatment) | Week 6 (treatment) | Week 7 (treatment) | |
| Lpc-37 | 7.31 | 7.53 | 7.66 | 7.77 | 7.73 | 7.90 | 7.77 |
| Placebo | 7.27 | 7.49 | 7.46 | 7.53 | 7.50 | 7.40 | 7.55 |
"Efficacy of the intake of Lpc-37 on the increase of perceived health status scores over the course of the treatment.~Measured with a daily online diary. Health status was rated by participants on an 11-point scale (0-10; not at all to very) and monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a high perceived health.Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Values reflect summary measures for perceived health status on a scale from 0 to 10 for the averaged ratings per participant and week." (NCT03494725)
Timeframe: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
| Intervention | score (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (run-in) | Week 2 (run-in) | Week 3 (treatment) | Week 4 (treatment) | Week 5 (treatment) | Week 6 (treatment) | Week 7 (treatment) | |
| Lpc-37 | 7.80 | 7.89 | 7.88 | 7.91 | 8.05 | 8.11 | 7.91 |
| Placebo | 7.86 | 7.92 | 7.92 | 8.01 | 7.92 | 7.73 | 7.75 |
"Efficacy of the intake of Lpc-37 on the increase of perceived productivity scores over the course of the treatment~Measured with a daily online diary. Productivity was rated by participants on an 11-point scale (0-10; not at all to very) and monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a higher perceived productivity. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group.Time is coded as a continuous variable with one value for each day and participant. The values reflect summary measures for perceived productivity on a scale from 0 to 10 for the averaged ratings per participant and week." (NCT03494725)
Timeframe: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
| Intervention | score (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (run-in) | Week 2 (run-in) | Week 3 (treatment) | Week 4 (treatment) | Week 5 (treatment) | Week 6 (treatment) | Week 7 (treatment) | |
| Lpc-37 | 6.98 | 7.34 | 7.53 | 7.48 | 7.59 | 7.57 | 7.50 |
| Placebo | 7.15 | 7.29 | 7.30 | 7.34 | 7.43 | 7.31 | 7.32 |
"Efficacy of the intake of Lpc-37 on the decrease of reported number of sleep disruptions over the course of the treatment measured with a daily online diary (mean of week summary).~Sleep disruptions were monitored through the wash-out phase (Week 1 and 2) and the subsequent treatment phase (Weeks 3-7). In the count version, the value can be 0 or a natural number for each day and each participant. Efficacy is defined as a decrease, or (in case of a general increase) reduced increase for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Values reflect summary measures for sleep disruptions (count) for the summed counts per participant and week." (NCT03494725)
Timeframe: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
| Intervention | sleep disruptions per participant & week (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (run-in) | Week 2 (run-in) | Week 3 (treatment) | Week 4 (treatment) | Week 5 (treatment) | Week 6 (treatment) | Week 7 (treatment) | |
| Lpc-37 | 7.30 | 5.50 | 4.89 | 5.43 | 3.52 | 3.80 | 4.66 |
| Placebo | 6.09 | 5.49 | 5.11 | 4.30 | 3.53 | 4.02 | 5.83 |
"Efficacy of the intake of Lpc-37 on the decrease of sleep disruptions over the course of the treatment measured with a daily online diary (Proportion (yes/total)).~Sleep disruptions were monitored through the wash-out phase and the subsequent treatment phase for each week. In the binary version, the value is either Yes or No for each day and each participant.~Efficacy is defined as a decrease, or (in case of a general increase) reduced increase for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant.~The proportion of participants with at least one sleep disruption by treatment group is given, treatment commenced after week 2. Data listed here reflect the proportion of participants who answered Yes (e.g. 0,477 * 44 = 20.99 participants answered with Yes in week 1 in the Lpc-37 group)." (NCT03494725)
Timeframe: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
| Intervention | Proportion of participants (yes/total) (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (run-in) | Week 2 (run-in) | Week 3 (treatment) | Week 4 (treatment) | Week 5 (treatment) | Week 6 (treatment) | Week 7 (treatment) | |
| Lpc-37 | 0.477 | 0.435 | 0.354 | 0.367 | 0.306 | 0.279 | 0.290 |
| Placebo | 0.465 | 0.426 | 0.418 | 0.310 | 0.292 | 0.331 | 0.389 |
Efficacy of the intake of Lpc-37 on reduction of the increase of salivary Alpha-Amylase (sAA) in response to the TSST compared to placebo. (NCT03494725)
Timeframe: 1 minute before the TSST and 1, 10, 20, 30 and 45 minutes after the TSST after 5 weeks of study product intake
| Intervention | U/ml (Mean) | |||||
|---|---|---|---|---|---|---|
| Pre-TSST -2min | Post-TSST +1min | Post-TSST +10min | Post-TSST +20min | Post-TSST +30min | Post-TSST +45min | |
| Lpc-37 | 154.04 | 246.29 | 146.53 | 130.11 | 125.19 | 141.13 |
| Placebo | 161.67 | 270.55 | 158.85 | 141.49 | 138.48 | 148.15 |
Efficacy of the intake of Lpc-37 on reduction of the increase of salivary cortisol in response to the TSST compared to placebo. (NCT03494725)
Timeframe: 1 minute before the TSST and 1, 10, 20, 30 and 45 minutes after the TSST after 5 weeks of study product intake
| Intervention | nmol/L (Mean) | |||||
|---|---|---|---|---|---|---|
| Pre-TSST -2min | Post-TSST +1min | Post-TSST +10min | Post-TSST +20min | Post-TSST +30min | Post-TSST +45min | |
| Lpc-37 | 4.79 | 6.96 | 9.48 | 9.89 | 8.04 | 6.21 |
| Placebo | 4.82 | 6.85 | 8.97 | 9.21 | 7.71 | 6.16 |
"Efficacy of the intake of Lpc-37 on the increase of sleep duration over the course of the treatment.~Sleep duration was monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Summary measures for Sleep duration for the averaged ratings per participant and week" (NCT03494725)
Timeframe: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
| Intervention | min (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (run-in) | Week 2 (run-in) | Week 3 (treatment) | Week 4 (treatment) | Week 5 (treatment) | Week 6 (treatment) | Week 7 (treatment) | |
| Lpc-37 | 447.27 | 444.01 | 449.45 | 450.62 | 454.50 | 450.88 | 445.60 |
| Placebo | 447.45 | 448.13 | 456.90 | 459.81 | 457.26 | 450.16 | 459.66 |
"Efficacy of the intake of Lpc-37 on the increase of sleep related recovery scores over the course of the treatment.~Measured with a daily online diary. Sleep related recovery was rated by participants on an 11-point scale (0-10; not at all to very) and monitored throughout the wash-out phase (Week 1 and 2) and the subsequent treatment phase (weeks 3-7). High scores indicate a high recovery.~Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Summary measures for sleep related recovery for the averaged ratings per participant and week." (NCT03494725)
Timeframe: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
| Intervention | score (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (run-in) | Week 2 (run-in) | Week 3 (treatment) | Week 4 (treatment) | Week 5 (treatment) | Week 6 (treatment) | Week 7 (treatment) | |
| Lpc-37 | 6.71 | 7.07 | 7.32 | 7.30 | 7.36 | 7.42 | 7.31 |
| Placebo | 6.91 | 7.15 | 7.27 | 7.29 | 7.36 | 7.10 | 7.28 |
"Efficacy of the intake of Lpc-37 on reduction of the increase of STAI-State scores in response to the TSST compared to placebo.~Measured with the german version of the State-Trait-Anxiety Inventory, scale anxiety as a temporary emotional state (STAI-X1). Answers are given on a four-point rating scale ranging from 1=not at all to 4=very true. The score range is 20-80; Higher scores indicate more anxiety." (NCT03494725)
Timeframe: 10 minutes before the TSST and 1 minute after the TSST after 5 weeks of study product intake
| Intervention | score (Mean) | |
|---|---|---|
| Pre-TSST -10min | Post-TSST +1min | |
| Lpc-37 | 36.09 | 42.38 |
| Placebo | 36.83 | 43.60 |
Efficacy of the intake of Lpc-37 on reduction of the increase of the systolic BP in response to the TSST compared to placebo. (NCT03494725)
Timeframe: 3 minutes before the TSST and 1 minute after the TSST after 5 weeks of study product intake
| Intervention | mmHg (Mean) | |
|---|---|---|
| Pre-TSST -3min | Post-TSST +1min | |
| Lpc-37 | 115.11 | 127.47 |
| Placebo | 114.33 | 129.19 |
Efficacy was defined as a lower increase in HR in response to the TSST following intervention with Lpc-37, compared to placebo. (NCT03494725)
Timeframe: Continuous measurement starting 20 minutes before and ending 20 minutes after the TSST after 5 weeks of product intake. Mean values were calculated per group at seven-time windows before, during and after the TSST
| Intervention | bpm (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Pre-TSST -20min | Pre-TSST -10min | Pre-TSST -3min | during TSST (Interview) | during TSST (Arithmetic) | Post-TSST +10min | Post-TSST +20min | |
| Lpc-37 | 74.84 | 88.15 | 97.34 | 107.56 | 102.77 | 93.32 | 75.88 |
| Placebo | 74.34 | 86.69 | 97.62 | 105.66 | 100.81 | 90.81 | 74.97 |
"Efficacy of the intake of Lpc-37 on reduction of the increase of VAS anxiety scores in response to the TSST compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater anxiety." (NCT03494725)
Timeframe: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
| Intervention | score (Mean) | ||
|---|---|---|---|
| Pre-TSST -10min | Interview TSST (during) | Post-TSST +1min | |
| Lpc-37 | 6.80 | 20.85 | 10.68 |
| Placebo | 8.50 | 22.47 | 11.74 |
"Efficacy of the intake of Lpc-37 on reduction of the increase of VAS exhaustion scores in response to the TSST compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater exhaustion." (NCT03494725)
Timeframe: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
| Intervention | score (Mean) | ||
|---|---|---|---|
| Pre-TSST -10min | Interview TSST (during) | Post-TSST +1min | |
| Lpc-37 | 21.18 | 19.20 | 22.12 |
| Placebo | 19.79 | 21.30 | 25.68 |
"Efficacy of the intake of Lpc-37 on reduction of the increase of VAS insecurity scores in response to the TSST compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater insecurity." (NCT03494725)
Timeframe: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
| Intervention | score (Mean) | ||
|---|---|---|---|
| Pre-TSST -10min | Interview TSST (during) | Post-TSST +1min | |
| Lpc-37 | 14.47 | 45.08 | 23.92 |
| Placebo | 17.19 | 52.19 | 23.69 |
"Efficacy of the intake of Lpc-37 on reduction of the increase of VAS Stress perception scores in response to the TSST compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating higher perceived stress." (NCT03494725)
Timeframe: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
| Intervention | score (Mean) | ||
|---|---|---|---|
| Pre-TSST -10min | Interview TSST (during) | Post-TSST +1min | |
| Lpc-37 | 19.89 | 47.71 | 31.72 |
| Placebo | 18.52 | 51.51 | 32.85 |
"Efficacy of the intake of Lpc-37 on the reduction of Beck Anxiety Inventory (BAI) scores compared to placebo.~Measured with the german version of the Beck Anxiety Inventory as a self-rating scale designed to measure anxiety. It comprises 21 sentences describing feelings that can occur when being anxious. These sentences are rated on a four-point rating scale ranging from 0=not at all to 3=severely, considering the last 7 days. The score range is 0-63; Higher scores indicate higher anxiety." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 5.51 | 4.75 |
| Placebo | 5.85 | 6.33 |
"Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) anxiety scores compared to placebo.~Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content.~Items are answered on a four point rating scale ranging from 0 = not at all to 3 = very much. Scores of each scale are calculated by summing the scores for the relevant items.~The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The items are 2, 4, 7, 9, 15, 19, 20, 23, 25, 28, 30, 36, 40, 41 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 2.60 | 2.44 |
| Placebo | 3.07 | 3.45 |
"Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) depression scores compared to placebo.~Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content.~Items are answered on a four point rating scale ranging from 0 = not at all to 3 = very much. Scores of each scale are calculated by summing the scores for the relevant items.~The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The items are 3, 5, 10, 13, 16, 17, 21, 24, 26, 31, 34, 37, 38, 42 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 4.60 | 4.15 |
| Placebo | 5.21 | 5.10 |
"Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) stress scores compared to placebo.~Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content.~Items are answered on a four point rating scale ranging from 0 = not at all to 3 = very much. Scores of each scale are calculated by summing the scores for the relevant items.~The stress scale (items) is sensitive to levels of chronic non-specific arousal.The stress scale items are 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 9.76 | 8.91 |
| Placebo | 9.41 | 10.09 |
Efficacy of the intake of Lpc-37 on the reduction of diastolic BP. (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 71.89 | 73.18 |
| Placebo | 71.68 | 74.62 |
"Efficacy of the intake of Lpc-37 on the reduction of Perceived Stress Scale (PSS) scores compared to placebo.~Measured with the german version of the PSS as a psychological instrument for measuring stress perception. It assesses how unpredictable, uncontrollable and overloaded participants perceived their lives to have been within the last month. The PSS comprises 14 items that are answered on a five-point rating scale ranging from 0 = never to 4 = very often. Individual scores on the PSS can range from 0 to 56 with higher scores indicating higher perceived stress." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 21.89 | 20.49 |
| Placebo | 20.72 | 21.56 |
"Efficacy of the intake of Lpc-37 on the reduction of State-Trait-Anxiety-Inventory (STAI)-state scores compared to placebo.~Measured with the german version of the State-Trait-Anxiety Inventory, scale anxiety as a temporary emotional state (STAI-X1). Answers are given on a four-point rating scale ranging from 1=not at all to 4=very true. The score range is 20-80; Higher scores indicate more anxiety." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 33.65 | 35.18 |
| Placebo | 34.33 | 35.33 |
Efficacy of the intake of Lpc-37 on the reduction of systolic blood pressure (BP). (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 119.60 | 121.87 |
| Placebo | 119.66 | 122.86 |
"Efficacy of the intake of Lpc-37 on the reduction of VAS anxiety scores compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater anxiety." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 7.29 | 9.26 |
| Placebo | 7.58 | 7.85 |
"Efficacy of the intake of Lpc-37 on the reduction of VAS exhaustion scores compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater exhaustion." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 29.56 | 24.66 |
| Placebo | 23.19 | 18.45 |
"Efficacy of the intake of Lpc-37 on the reduction of VAS insecurity scores compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater insecurity." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 13.58 | 16.44 |
| Placebo | 15.91 | 17.30 |
"Efficacy of the intake of Lpc-37 on the reduction of Visual Analog Scale (VAS) stress perception scores compared to placebo.~Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from not at all to highly. The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating higher perceived stress." (NCT03494725)
Timeframe: Before and after 5 weeks of study product intake.
| Intervention | score (Mean) | |
|---|---|---|
| Baseline | End of Study | |
| Lpc-37 | 19.11 | 23.32 |
| Placebo | 19.34 | 20.67 |
"Efficacy of the intake of Lpc-37 on the reduction of the difference of cortisol at 8 pm values to the respective mean before and after 5 weeks of treatment~Efficacy for the CAR variable cortisol at 8 pm is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy." (NCT03494725)
Timeframe: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake
| Intervention | number of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Baseline (<25% quantile) | Baseline (25% - 75% quantile) | Baseline (>75% quantile) | End of Study (<25% quantile) | End of Study (25% - 75% quantile) | End of Study (>75% quantile) | |
| Lpc-37 | 4 | 20 | 29 | 3 | 28 | 22 |
| Placebo | 6 | 23 | 26 | 7 | 18 | 30 |
"Efficacy of the intake of Lpc-37 on the reduction of the difference of Cortisol Awakening Response (CAR) area under the curve with respect to the ground (AUCg) values to the respective mean before and after 5 weeks of treatment.~The CAR is summarized in the variables AUCg, AUCi, mean increase and peak value. These cortisol indices are frequently used to describe hypothalamic-pituitary-adrenal axis activity and represent information either of the total cortisol production or of the change in cortisol levels. AUCg is the total area under the curve of all measurements (i.e., the intensity or magnitude of the response).~Efficacy for the CAR variables AUCg is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy." (NCT03494725)
Timeframe: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake)
| Intervention | number of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Baseline (<25% quantile) | Baseline (25% - 75% quantile) | Baseline (>75% quantile) | End of Study (<25% quantile) | End of Study (25% - 75% quantile) | End of Study (>75% quantile) | |
| Lpc-37 | 6 | 36 | 11 | 11 | 28 | 14 |
| Placebo | 12 | 30 | 13 | 7 | 35 | 13 |
"Efficacy of the intake of Lpc-37 on the reduction of the difference of Cortisol at Awakening values to the respective mean before and after 5 weeks of treatment~Efficacy for the CAR variable cortisol at awakening is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy." (NCT03494725)
Timeframe: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake)
| Intervention | number of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Baseline (<25% quantile) | Baseline (25% - 75% quantile) | Baseline (>75% quantile) | End of Study (<25% quantile) | End of Study (25% - 75% quantile) | End of Study (>75% quantile) | |
| Lpc-37 | 14 | 31 | 8 | 19 | 26 | 8 |
| Placebo | 16 | 26 | 13 | 12 | 34 | 9 |
"Efficacy of the intake of Lpc-37 on the reduction of the difference of CAR area under the curve with respect to the increase (AUCi) values to the respective mean before and after the treatment.~The CAR is summarized in the variables AUCg, AUCi, mean increase and peak value. These cortisol indices are frequently used to describe hypothalamic-pituitary-adrenal axis activity and represent information either of the total cortisol production or of the change in cortisol levels. AUCi is calculated with reference to the baseline measurement and it ignores the distance from zero for all measurements and emphasizes the changes over time. Efficacy for the CAR variables AUCi is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy." (NCT03494725)
Timeframe: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake)
| Intervention | number of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Baseline (<25% quantile) | Baseline (25% - 75% quantile) | Baseline (>75% quantile) | End of Study (<25% quantile) | End of Study (25% - 75% quantile) | End of Study (>75% quantile) | |
| Lpc-37 | 16 | 34 | 3 | 15 | 34 | 4 |
| Placebo | 22 | 28 | 5 | 15 | 36 | 4 |
The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108-115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline. (NCT01696929)
Timeframe: Change in BACS composite score from baseline to 8 weeks
| Intervention | Change in BACS Composite Score (Mean) |
|---|---|
| Tocilizumab | 0.7 |
The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology. (NCT01696929)
Timeframe: Change in PANSS total score from baseline to 8 weeks
| Intervention | Change in PANSS Total Score (Mean) |
|---|---|
| Tocilizumab | -2.6 |
11 reviews available for kynurenine and Depression, Endogenous
| Article | Year |
|---|---|
Oxidative and Nitrosative Stress as Well as the Tryptophan Catabolites Pathway in Depressive Disorders.
Topics: Antidepressive Agents; Antioxidants; Biomarkers; Depression; Depressive Disorder; Disease Progressio | 2017 |
Kynurenine pathway in depression: A systematic review and meta-analysis.
Topics: Brain; Depression; Depressive Disorder; Humans; Kynurenic Acid; Kynurenine; Quinolinic Acid | 2018 |
[The importance of the kynurenine pathway in depressive disorders].
Topics: Antidepressive Agents; Depressive Disorder; Humans; Kynurenine; Metabolic Networks and Pathways; Try | 2018 |
Is there a role for glutamate-mediated excitotoxicity in inflammation-induced depression?
Topics: Animals; Blood-Brain Barrier; Depressive Disorder; Glutamic Acid; Humans; Indoleamine-Pyrrole 2,3,-D | 2014 |
Cognition and Emotions in Recurrent Depressive Disorders - The Role of Inflammation and the Kynurenine Pathway.
Topics: Animals; Cognition; Depressive Disorder; Emotions; Humans; Inflammation; Kynurenine; Recurrence; Sig | 2016 |
Role of the Kynurenine Metabolism Pathway in Inflammation-Induced Depression: Preclinical Approaches.
Topics: Animals; Depressive Disorder; Humans; Inflammation; Kynurenine; Metabolic Networks and Pathways; Neu | 2017 |
Inflammation, glutamate, and glia in depression: a literature review.
Topics: Animals; Astrocytes; Brain; Depressive Disorder; Disease Models, Animal; Glutamic Acid; Humans; Infl | 2008 |
COX-2 inhibitors as antidepressants and antipsychotics: clinical evidence.
Topics: Animals; Antidepressive Agents; Antipsychotic Agents; Cyclooxygenase 2 Inhibitors; Cytokines; Depres | 2010 |
COX-2 inhibitors as antidepressants and antipsychotics: clinical evidence.
Topics: Animals; Antidepressive Agents; Antipsychotic Agents; Cyclooxygenase 2 Inhibitors; Cytokines; Depres | 2010 |
COX-2 inhibitors as antidepressants and antipsychotics: clinical evidence.
Topics: Animals; Antidepressive Agents; Antipsychotic Agents; Cyclooxygenase 2 Inhibitors; Cytokines; Depres | 2010 |
COX-2 inhibitors as antidepressants and antipsychotics: clinical evidence.
Topics: Animals; Antidepressive Agents; Antipsychotic Agents; Cyclooxygenase 2 Inhibitors; Cytokines; Depres | 2010 |
Inflammatory biomarkers and depression.
Topics: Animals; Antidepressive Agents; Biomarkers; Cyclooxygenase 2 Inhibitors; Depressive Disorder; Humans | 2011 |
Pathobiological targets of depression.
Topics: Animals; Antidepressive Agents; Clinical Trials as Topic; Cytokines; Depressive Disorder; Disease Mo | 2011 |
Interferon-induced depression: mechanisms and management.
Topics: Cyclooxygenase 2; Depressive Disorder; Female; Humans; Hypothalamo-Hypophyseal System; Interferon-al | 2007 |
2 trials available for kynurenine and Depression, Endogenous
| Article | Year |
|---|---|
Kynurenine in blood plasma and DST in patients with endogenous anxiety and endogenous depression.
Topics: Adrenal Cortex Hormones; Adult; Anxiety Disorders; Bipolar Disorder; Depressive Disorder; Dexamethas | 1994 |
Increased depressive ratings in patients with hepatitis C receiving interferon-alpha-based immunotherapy are related to interferon-alpha-induced changes in the serotonergic system.
Topics: Adult; Depressive Disorder; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; | 2002 |
33 other studies available for kynurenine and Depression, Endogenous
| Article | Year |
|---|---|
HMGB1 mediates depressive behavior induced by chronic stress through activating the kynurenine pathway.
Topics: Animals; Depression; Depressive Disorder; Hippocampus; HMGB1 Protein; Hydrolases; Indoleamine-Pyrrol | 2018 |
Glycyrrhizic acid ameliorates the kynurenine pathway in association with its antidepressant effect.
Topics: Animals; Antidepressive Agents; Depressive Disorder; Disease Models, Animal; Glycyrrhizic Acid; HMGB | 2018 |
Psychosocial stress and inflammation driving tryptophan breakdown in children and adolescents: A cross-sectional analysis of two cohorts.
Topics: Adolescent; C-Reactive Protein; Child; Cohort Studies; Cross-Sectional Studies; Cytokines; Depressio | 2018 |
Leucine competes with kynurenine for blood-to-brain transport and prevents lipopolysaccharide-induced depression-like behavior in mice.
Topics: Amino Acid Transport System y+L; Animals; Antidepressive Agents; Behavior, Animal; Blood-Brain Barri | 2019 |
Alterations in the metabolism of tryptophan in patients with chronic hepatitis C six months after pegylated interferon-α 2a treatment.
Topics: Adult; Antiviral Agents; Depression; Depressive Disorder; Female; Hepatitis C; Hepatitis C, Chronic; | 2018 |
A step ahead: Exploring the gut microbiota in inpatients with bipolar disorder during a depressive episode.
Topics: Biomarkers; Bipolar Disorder; Case-Control Studies; Cross-Sectional Studies; Depression; Depressive | 2019 |
Exercise Your Kynurenines to Fight Depression.
Topics: Depression; Depressive Disorder; Exercise; Humans; Kynurenine; Muscle, Skeletal | 2018 |
[Tryptophan Metabolites in Plasma of Patients with Depression].
Topics: Bipolar Disorder; Depressive Disorder; Humans; Kynurenine; Tryptophan | 2018 |
Antidepressant effect of repeated ketamine administration on kynurenine pathway metabolites in patients with unipolar and bipolar depression.
Topics: Administration, Intravenous; Adult; Antidepressive Agents; Bipolar Disorder; China; Chromatography, | 2018 |
Ketamine and depression: A special kase for kynurenic acid?
Topics: Animals; Antidepressive Agents; Depression; Depressive Disorder; Humans; Ketamine; Kynurenic Acid; K | 2019 |
Indoleamine 2,3-Dioxygenase-Dependent Neurotoxic Kynurenine Metabolism Contributes to Poststroke Depression Induced in Mice by Ischemic Stroke along with Spatial Restraint Stress.
Topics: 3-Hydroxyanthranilate 3,4-Dioxygenase; Animals; Brain Ischemia; Depressive Disorder; Indoleamine-Pyr | 2018 |
How acute and chronic physical disease may influence mental health - An Analysis of neurotransmitter precursor amino acid levels.
Topics: Acute Disease; Adult; Aged; Amino Acids; Anxiety Disorders; C-Reactive Protein; Chronic Disease; Dep | 2019 |
Impact of physical exercise on the kynurenine pathway in patients with cancer: current limitations and future perspectives.
Topics: Depression; Depressive Disorder; Exercise; Humans; Kynurenine; Neoplasms | 2019 |
Fr‑HMGB1 and ds‑HMGB1 activate the kynurenine pathway via different mechanisms in association with depressive‑like behavior.
Topics: Animals; Behavior, Animal; Depression; Depressive Disorder; Disulfides; Enzyme-Linked Immunosorbent | 2019 |
A biopsychosocial model of interferon-alpha-induced depression in patients with chronic hepatitis C infection.
Topics: Adult; Analysis of Variance; Depressive Disorder; Female; Hepatitis C, Chronic; Humans; Indoleamine- | 2013 |
Inhibition of stress-induced hepatic tryptophan 2,3-dioxygenase exhibits antidepressant activity in an animal model of depressive behaviour.
Topics: Allopurinol; Animals; Antidepressive Agents; Cerebral Cortex; Chronic Disease; Corticosterone; Depre | 2014 |
A role for inflammatory metabolites as modulators of the glutamate N-methyl-D-aspartate receptor in depression and suicidality.
Topics: Adult; Cytokines; Depressive Disorder; Female; Humans; Inflammation; Kynurenic Acid; Kynurenine; Mal | 2015 |
Muscling in on depression.
Topics: Animals; Depressive Disorder; Exercise; Humans; Kynurenine; Mice; Muscle, Skeletal; Peroxisome Proli | 2014 |
Etiological classification of depression based on the enzymes of tryptophan metabolism.
Topics: Antidepressive Agents; Brain; Depressive Disorder; Humans; Hypothalamo-Hypophyseal System; Indoleami | 2014 |
The impact of electroconvulsive therapy on the tryptophan-kynurenine metabolic pathway.
Topics: Adult; Aged; Depressive Disorder; Electroconvulsive Therapy; Female; Humans; Kynurenic Acid; Kynuren | 2015 |
Induction of depression-related behaviors by reactivation of chronic Toxoplasma gondii infection in mice.
Topics: Animals; Brain; Chronic Disease; Depressive Disorder; Dietary Sucrose; Disease Models, Animal; Dopam | 2016 |
Inflammation, immunology, stress and depression: a role for kynurenine metabolism in physical exercise and skeletal muscle.
Topics: Depression; Depressive Disorder; Exercise; Humans; Inflammation; Kynurenine; Muscle, Skeletal; Stres | 2016 |
Reduced kynurenine pathway metabolism and cytokine expression in the prefrontal cortex of depressed individuals.
Topics: Adult; Cytokines; Depressive Disorder; Female; Humans; Immunohistochemistry; Kynurenine; Male; Polym | 2016 |
Female Flinders Sensitive Line rats show estrous cycle-independent depression-like behavior and altered tryptophan metabolism.
Topics: 5-Hydroxytryptophan; Animals; Anxiety; Brain; Depressive Disorder; Disease Models, Animal; Estrous C | 2016 |
Decreased levels of kynurenic acid in prefrontal cortex in a genetic animal model of depression.
Topics: Animals; Cerebellum; Chromatography, Liquid; Corpus Striatum; Depressive Disorder; Disease Models, A | 2017 |
Microbiota alteration is associated with the development of stress-induced despair behavior.
Topics: Animals; Depressive Disorder; Gastrointestinal Microbiome; Indoleamine-Pyrrole 2,3,-Dioxygenase; Int | 2017 |
Microbiota alteration is associated with the development of stress-induced despair behavior.
Topics: Animals; Depressive Disorder; Gastrointestinal Microbiome; Indoleamine-Pyrrole 2,3,-Dioxygenase; Int | 2017 |
Microbiota alteration is associated with the development of stress-induced despair behavior.
Topics: Animals; Depressive Disorder; Gastrointestinal Microbiome; Indoleamine-Pyrrole 2,3,-Dioxygenase; Int | 2017 |
Microbiota alteration is associated with the development of stress-induced despair behavior.
Topics: Animals; Depressive Disorder; Gastrointestinal Microbiome; Indoleamine-Pyrrole 2,3,-Dioxygenase; Int | 2017 |
[Impact of interferon alpha immunotherapy on tryptophan metabolism in patients with chronic hepatitis C. Results of a pilot studies on ten patients].
Topics: Adult; Antiviral Agents; Anxiety Disorders; Blood Platelets; Depressive Disorder; Female; Hepatitis | 2009 |
The possible role of the kynurenine pathway in adolescent depression with melancholic features.
Topics: 3-Hydroxyanthranilic Acid; Adolescent; Child; Cytokines; Depressive Disorder; Depressive Disorder, M | 2010 |
Kynurenine pathway in major depression: evidence of impaired neuroprotection.
Topics: Adult; Depressive Disorder; Female; Humans; Kynurenine; Male; Middle Aged; Neuroprotective Agents; P | 2007 |
Kynurenine pathway in major depression: evidence of impaired neuroprotection.
Topics: Adult; Depressive Disorder; Female; Humans; Kynurenine; Male; Middle Aged; Neuroprotective Agents; P | 2007 |
Kynurenine pathway in major depression: evidence of impaired neuroprotection.
Topics: Adult; Depressive Disorder; Female; Humans; Kynurenine; Male; Middle Aged; Neuroprotective Agents; P | 2007 |
Kynurenine pathway in major depression: evidence of impaired neuroprotection.
Topics: Adult; Depressive Disorder; Female; Humans; Kynurenine; Male; Middle Aged; Neuroprotective Agents; P | 2007 |
The immune effects of TRYCATs (tryptophan catabolites along the IDO pathway): relevance for depression - and other conditions characterized by tryptophan depletion induced by inflammation.
Topics: Adult; Anti-Inflammatory Agents; Cytokines; Depressive Disorder; Female; Gene Expression Regulation; | 2007 |
Tryptophan tolerance and metabolism in endogenous depression.
Topics: Adult; Aged; Depressive Disorder; Female; Humans; Kinetics; Kynurenine; Metabolic Clearance Rate; Mi | 1982 |
Effect of oral contraceptives on tryptophan and tyrosine availability: evidence for a possible contribution to mental depression.
Topics: Adult; Brain Chemistry; Contraceptives, Oral; Contraceptives, Oral, Combined; Depressive Disorder; E | 1981 |
[Plasma kynurenine levels and the dexamethasone test in patients with endogenous anxiety disorders and depression].
Topics: 11-Hydroxycorticosteroids; Adult; Anxiety Disorders; Depressive Disorder; Dexamethasone; Diagnosis, | 1990 |