scholarly journals An Open-label Clinical Study of Chronic L-theanine Supplementation in Patients with Major Depressive Disorder (P12-007-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Shinsuke Hidese ◽  
Miho Ota ◽  
Hayato Ozawa ◽  
Tsutomu Okubo ◽  
Hiroshi Kunugi
Keyword(s):  
Clinical Study ◽  
Cognitive Functions ◽  
Verbal Memory ◽  
Rating Scale ◽  
Stroop Test ◽  
Open Label ◽  
Beneficial Effects ◽  
Funding Sources ◽  
Brief Assessment ◽  
Current Medication

Abstract Objectives The present study is designed to investigate the effectiveness of L-theanine (Suntheanine®) among patients with major depression disorder (MDD). Methods Twenty patients were recruited with moderate MDD (4 males; mean age: 41.0 ± 14.1 years, and 16 females; 42.9 ± 12.0 years) for this open-label clinical study. Participants were supplemented with L-theanine (250 mg/day) along with their current medication for 8 consecutive weeks. The cognitive functions and related symptoms were evaluated at baseline, 4 weeks, and 8 weeks after L-theanine supplementation using advanced version (21-items) of the Hamilton Depression Rating Scale (HAMD-21), Pittsburgh Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI), Brief Assessment of Cognition in Schizophrenia (BACS), including the Stroop test. Results L-theanine supplementation effectively lowered the HAMD-21 score (P = 0.007), and reduction was also observed in unremitted patients (HAMD-21 > 7; P = 0.004) at baseline. STAI test results indicated a significant decrease in Anxiety-trait scores (P = 0.012) after L-theanine supplementation. PSQI scores also decreased in the unremitted patients at baseline after L-theanine intake (P = 0.030). Concerning to the cognitive functions, response latency (P = 0.001) and error rate (P = 0.036) were lowered in the Stroop test, while executive function (P = 0.016) and verbal memory (P = 0.005) were significantly enhanced in the BACS test after L-theanine supplementation. Conclusions This study demonstrates that chronic L-theanine supplementation (8 weeks) is quite safe and features with diverse beneficial effects on the improvement of depressive symptoms, sleep disturbance, anxiety, and cognitive impairment functions in patients with MDD. Funding Sources This study was supported by an unrestricted research grant provided by the Taiyo Kagaku Co. Ltd.

scholarly journals Effects of chronic l-theanine administration in patients with major depressive disorder: an open-label study

2016 ◽  
Vol 29 (2) ◽  
pp. 72-79 ◽  
Author(s):  
Shinsuke Hidese ◽  
Miho Ota ◽  
Chisato Wakabayashi ◽  
Takamasa Noda ◽  
Hayato Ozawa ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Cognitive Functions ◽  
Verbal Memory ◽  
Rating Scale ◽  
Stroop Test ◽  
Open Label ◽  
Major Depressive ◽  
Open Label Study ◽  
Label Study

Objectivel-theanine, an amino acid uniquely contained in green tea (Camellia sinensis), has been suggested to have various psychotropic effects. This study aimed to examine whether l-theanine is effective for patients with major depressive disorder (MDD) in an open-label clinical trial.MethodsSubjects were 20 patients with MDD (four males; mean age: 41.0±14.1 years, 16 females; 42.9±12.0 years). l-theanine (250 mg/day) was added to the current medication of each participant for 8 weeks. Symptoms and cognitive functions were assessed at baseline, 4, and 8 weeks after l-theanine administration by the 21-item version of the Hamilton Depression Rating Scale (HAMD-21), State-Trait Anxiety Inventory (STAI), Pittsburgh Sleep Quality Index (PSQI), Stroop test, and Brief Assessment of Cognition in Schizophrenia (BACS).ResultsHAMD-21 score was reduced after l-theanine administration (p=0.007). This reduction was observed in unremitted patients (HAMD-21>7; p=0.004) at baseline. Anxiety-trait scores decreased after l-theanine administration (p=0.012) in the STAI test. PSQI scores also decreased after l-theanine administration (p=0.030) in the unremitted patients at baseline. Regarding cognitive functions, response latency (p=0.001) and error rate (p=0.036) decreased in the Stroop test, and verbal memory (p=0.005) and executive function (p=0.016) were enhanced in the BACS test after l-theanine administration.ConclusionOur study suggests that chronic (8-week) l-theanine administration is safe and has multiple beneficial effects on depressive symptoms, anxiety, sleep disturbance and cognitive impairments in patients with MDD. However, since this is an open-label study, placebo-controlled studies are required to consolidate the effects.

scholarly journals Effects of Chronic L-theanine on Stress-related Symptoms and Cognitive Function in a Non-clinical Population: A Randomized Controlled Trial (P06-106-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Hiroshi Kunugi ◽  
Shinsuke Hidese ◽  
Shintaro Ogawa ◽  
Miho Ota ◽  
Zenta Yasukawa ◽  
...  
Keyword(s):  
Executive Function ◽  
Placebo Group ◽  
Crossover Study ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Depression Scale ◽  
Clinical Population ◽  
Double Blind ◽  
Funding Sources ◽  
Brief Assessment

Abstract Objectives This randomized, placebo-controlled, and double-blind, crossover study aimed to investigate the effects of chronic L-theanine (Suntheanine®) administration on stress-related symptoms and cognitive functions in a non-clinical population. Methods Participants were 9 men and 21 women (mean age: 48.3 ± 11.9 years) who had no psychiatric illness of clinical level. L-theanine (200 mg/day) or placebo tablets were randomly assigned to participants for 4 weeks administration. After 2 weeks of wash-out period, the crossover study was continued for 4 weeks. Stress related symptoms were assessed using Self-rating Depression Scale (SDS), State-Trait Anxiety Inventory (STAI), and Pittsburgh Sleep Quality Index (PSQI). Cognitive functions were assessed with Brief Assessment of Cognition in Schizophrenia (BACS). Results SDS, STAI-trait, and PSQI scores significantly decreased after 4 weeks of L-theanine administration, while there were no significant changes after placebo. Verbal fluency and executive function scores of BACS significantly increased (p = 0.001 and 0.031) after L-theanine, but not placebo, administration. Changes in sleep latency, sleep disturbance, and use of sleep medication subscales of PSQI were significantly better in the L-theanine than in the placebo group. Changes in SDS and PSQI total scores also tended to be better in L-theanine than in placebo group. The rate of individuals who showed an improvement in BACS executive function score (5 or more) was significantly greater in L-theanine group than in placebo group. There was no significant adverse event after chronic L-theanine administration. Conclusions The results suggest that 4 weeks of L-theanine (200 mg/day) administration is safe and effective on stress-related symptoms and cognitive functions in a non-clinical population. Funding Sources This research was funded by Taiyo Kagaku, Co. Ltd.

scholarly journals Evaluation of the efficacy and tolerability of naftidrofuryl in the therapy of chronic cerebral ischemia

2021 ◽  
Vol 13 (1) ◽  
pp. 38-43
Author(s):  
M. N. Dadasheva ◽  
I. A. Zolotovskaya ◽  
R. V. Gorenkov ◽  
K. N. Dadasheva ◽  
D. I. Lebedeva
Keyword(s):  
Cerebral Ischemia ◽  
Anxiety Disorders ◽  
Cognitive Functions ◽  
High Efficiency ◽  
Rating Scale ◽  
Chronic Cerebral Ischemia ◽  
Open Label ◽  
Multicenter Observational Study ◽  
Self Rating ◽  
Number Of Patients

Objective: to study the clinical efficacy and tolerability of naftidrofuryl (Duzofarm®) in patients with chronic cerebral ischemia (CCI).Patients and methods. A prospective open-label multicenter observational study evaluated the clinical efficiency and tolerability of naftidrofuryl treatment in patients with CCI. To statistically evaluate the efficacy and tolerability of naftidrofuryl, the investigators used data from 200 outpatients with Stages I–II CCI who were included in the program of treatment and received its full cycle. The patients were prescribed naftidrofuryl at a dose of 100 mg (2 tablets) thrice daily. Basic therapy that the patients had received before their inclusion in the observation program was not discontinued. The patients' status was evaluated using a specially designed questionnaire. Four visits were scheduled. All the patients underwent neurological examination. To study the patients' cognitive functions and emotional state, the investigators used the following tests and scales: the Mini-Cog test, the Mini-Mental State Examination (MMSE), the Zung Self-Rating Anxiety Scale, the Asthenia Subjective Assessment Scale, and the Modified Scoring Scale for Subjective Sleep Characteristics. Adverse reactions were recorded to evaluate the tolerability of therapy.Results and discussion. Naftidrofuryl therapy significantly improved health and reversed complaints in the patients. By the end of the treatment cycle, there was a significant improvement on all scales, which suggested a decrease in the severity of cognitive impairment and asthenic and mild anxiety disorders. When performing the Mini-Cog test, the proportion of patients who were able to remember and recall three words without errors increased from 43 to 86%, and when doing the clock drawing test, the proportion increased by 65%. Cognitive functions on the MMSE were observed to statistically significantly improve by 1.2 scores. According to the Zung Anxiety Self-Rating Scale, the number of patients with anxiety disorders decreased by 24%, those with insomnia significantly declined by 31% compared with the baseline level.Conclusion. The findings showed the high efficiency and appropriateness of naftidrofuryl administration to patients with Stages I–II CCI and hypertension.

scholarly journals Pharmacokinetics of a Novel Form of Biotin, Magnesium Biotinate, in Healthy Subjects (P06-027-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Sara Perez Ojalvo ◽  
Sarah Sylla ◽  
James Komorowski
Keyword(s):  
Clinical Study ◽  
Peak Plasma ◽  
Plasma Concentrations ◽  
Area Under The Curve ◽  
Blood Levels ◽  
Pharmacokinetic Data ◽  
Open Label ◽  
Post Dose ◽  
Funding Sources ◽  
Study Results

Abstract Objectives Biotin, also known as vitamin B7, plays an important role in the metabolization of nutrients into energy. Magnesium biotinate (MgB) is a novel biotin compound that has been shown to be 40 times more soluble than D-Biotin. Preclinical evidence has shown that MgB is well absorbed into the bloodstream and tissues, particularly the brain, over time. The following pharmacokinetic study was carried out to further explore the absorption and bioavailability of MgB. Methods In an open-label clinical study, 30 healthy female subjects (18–45 years, BMI 18.0–29.9 kg/m2) were randomized to receive a single oral capsule containing one of the following doses of MgB (n = 10 per group): 1) 10 mg MgB, 2) 40 mg MgB, 3) 100 mg MgB. Serial blood samples were collected in K2-EDTA tubes at pre-dose (within 1 hour of dose) and at 0.5, 1.0, 1.5, 3.0 and 6.0 hours post-dose. Plasma samples were analyzed for biotin by LC/MS/MS. Pharmacokinetic data were calculated for each dose group. Results Study results showed that plasma biotin levels increased at 0.5, 1.0, 1.5, 3.0 and 6.0 hours post-dose for all groups. However, the largest biotin increase was seen in the 100 mg group (Figure 1). Peak plasma concentrations were observed as follows: 84.8 ng/mL 1 hour after a 10 mg dose, 214.6 ng/mL 1.5 hours after a 40 mg dose, and 508.5 ng/mL 1.5 hours after a 100 mg dose. Area under the curve values increased with increasing biotin dose level (10 mg: 210.0 ng*h/mL; 40 mg: 605.1 ng*h/mL; 100 mg: 1652.4 ng*h/mL). No adverse effects were observed. Conclusions Results from this single-dose pharmacokinetic clinical study demonstrate that magnesium biotinate is a bioavailable form of biotin, with increasing blood levels associated with increasing dose levels. Funding Sources This study was funded by JDS Therapeutics, LLC. Supporting Tables, Images and/or Graphs

scholarly journals M54. ASSOCIATIONS BETWEEN MUSICAL ABILITY SUBSCALE PERFORMANCE, PSYCHIATRIC SYMPTOMS, AND COGNITIVE FUNCTIONING IN SCHIZOPHRENIA

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S154-S155
Author(s):  
Yoshiki Akagawa ◽  
William Honer ◽  
Ken Sawada
Keyword(s):  
Processing Speed ◽  
Cognitive Functions ◽  
Verbal Memory ◽  
Negative Symptoms ◽  
Psychiatric Symptoms ◽  
Musical Ability ◽  
Motor Speed ◽  
Word Fluency ◽  
Brief Assessment ◽  
Musical Memory

Abstract Background Several studies showed that patients with schizophrenia have a lower musical ability that correlates with poorer cognitive functions and severer negative symptoms. Despite the strong relevance of musical ability to cognitive functions and psychiatric symptoms, little is known about the correlation of each subscale of musical ability to cognitive functions and psychiatric symptoms. Therefore, we sought to analyze the correlations of the subtests of musical ability to cognitive functions and psychiatric symptoms. Methods Sixty-four patients with schizophrenia (36 males, mean age = 48.6 ± 10.9 years old) and 80 healthy control subjects (44 males, mean age = 45.3 ± 12.3 years old) consented to participate. We measured musical ability, cognitive functions, and symptom severity using the Montreal Battery for Evaluation of Amusia (MBEA), Brief Assessment of Cognition in Schizophrenia (BACS), and Positive and Negative Syndrome Scale (PANSS), respectively. MBEA subscales include melody discrimination, rhythm discrimination, and musical memory. BACS subscales are comprised of verbal memory, working memory, motor speed, word fluency, attention/processing speed, and executive function. We used the Bonferroni correction for multiple comparisons. For the BACS six subscales, and the three musical subscales, we considered p < 0.00278 to be significant (18 tests), and for PANSS three symptom subscale scores and three musical subscales, we considered p < 0.0056 to be significant (9 tests). Results All musical subscale scores of patients were significantly lower than controls. Lower musical ability subscales were correlated with lower cognitive functions in both healthy controls and patients. In schizophrenia, as previously reported, there were associations between lower musical ability subscales, lower cognitive functions, and more severe psychiatric symptoms. In patients with schizophrenia, while melody discrimination was not correlated with cognitive functions, rhythm discrimination was correlated with verbal memory (beta = 0.378, SE= 0.010, t = 3.42, p = 0.0012) and attention/processing speed (beta = 0.433, SE= 0.013, t = 3.20, p = 0.0022) adjusted for age, gender, and years of musical education. PANSS negative symptoms were correlated with melody discrimination (beta = 0.346, SE= 0.051, t = -2.82, p = 0.0066) and rhythm discrimination (beta = 0.3259, SE= 0.045, t = -2.88, p = 0.0056), but not musical memory. Discussion This study revealed an association between performance on rhythm discrimination and both verbal memory and word fluency. Furthermore, more severe negative symptoms were associated with lower abilities in melody and rhythm discrimination. Rhythm discrimination could be associated with language disturbances, possibly providing a new insight into the language and musical deficits contributing to the pathophysiology of schizophrenia.

scholarly journals Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Scott H. Kollins ◽  
Ann Childress ◽  
Andrew C. Heusser ◽  
Jacqueline Lutz
Keyword(s):  
Video Game ◽  
Primary Outcome ◽  
Rating Scale ◽  
Stimulant Medication ◽  
Additional Treatment ◽  
Adhd Medication ◽  
Open Label ◽  
Serious Adverse Events ◽  
Treatment Benefit ◽  
Hyperactivity Disorder

AbstractSTARS-Adjunct was a multicenter, open-label effectiveness study of AKL-T01, an app and video-game-based treatment for inattention, as an adjunct to pharmacotherapy in 8–14-year-old children with attention-deficit/hyperactivity disorder (ADHD) on stimulant medication (n = 130) or not on any ADHD medication (n = 76). Children used AKL-T01 for 4 weeks, followed by a 4-week pause and another 4-week treatment. The primary outcome was change in ADHD-related impairment (Impairment Rating Scale (IRS)) after 4 weeks. Secondary outcomes included changes in IRS, ADHD Rating Scale (ADHD-RS). and Clinical Global Impressions Scale—Improvement (CGI-I) on days 28, 56, and 84. IRS significantly improved in both cohorts (On Stimulants: −0.7, p < 0.001; No Stimulants: −0.5, p < 0.001) after 4 weeks. IRS, ADHD-RS, and CGI-I remained stable during the pause and improved with a second treatment period. The treatment was well-tolerated with no serious adverse events. STARS-Adjunct extends AKL-T01’s body of evidence to a medication-treated pediatric ADHD population, and suggests additional treatment benefit.

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