scholarly journals Repeated oral ketamine for out-patient treatment of resistant depression: randomised, double-blind, placebo-controlled, proof-of-concept study

2018 ◽  
Vol 214 (1) ◽  
pp. 20-26 ◽  
Author(s):  
Yoav Domany ◽  
Maya Bleich-Cohen ◽  
Ricardo Tarrasch ◽  
Roi Meidan ◽  
Olga Litvak-Lazar ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Rating Scale ◽  
Control Group ◽  
Number Needed To Treat ◽  
Proof Of Concept ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oral Ketamine ◽  
Group A ◽  
Resistant Depression

BackgroundKetamine has been demonstrated to improve depressive symptoms.AimsEvaluation of efficacy, safety and feasibility of repeated oral ketamine for out-patients with treatment-resistant depression (TRD).MethodIn a randomised, double-blind, placebo-controlled, proof-of-concept trial, 41 participants received either 1 mg/kg oral ketamine or placebo thrice weekly for 21 days (ClinicalTrials.gov Identifier: NCT02037503). Evaluation was performed at baseline, 40 and 240 min post administration and on days 3, 7, 14 and 21. The main outcome measure was change in Montgomery–Åsberg Depression Rating Scale (MADRS).ResultsTwenty-two participants were randomised to the ketamine group, and 19 to the control, with 82.5% (n = 33) completing the study. In the ketamine group, a decrease in depressive symptoms was evident at all time points, whereas in the control group a decrease was evident only 40 min post administration. The reduction in MADRS score on day 21 was 12.75 in the ketamine group versus 2.49 points with placebo (P < 0.001). Six participants in the ketamine group (27.3%) achieved remission compared with none of the controls (P < 0.05). The number needed to treat for remission was 3.7. Side-effects were mild and transient.ConclusionsRepeated oral ketamine produced rapid and persistent amelioration of depressive symptoms in out-patients with TRD, and was well tolerated. These results suggest that add-on oral ketamine may hold significant promise in the care of patients suffering from TRD in the community.Declaration of interestNone.

scholarly journals Intravenous methylcobalamin effectively ameliorated painful diabetic neuropathy: A randomized double-blind placebo controlled trial

2021 ◽  
Vol 20 (3) ◽  
pp. 335-341
Author(s):  
Thomas Eko Purwata ◽  
◽  
I Putu Eka Widyadharma ◽  
Made Rudy ◽  
Andreas Soejitno ◽  
...  
Keyword(s):  
Treatment Group ◽  
Diabetic Neuropathy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Painful Diabetic Neuropathy ◽  
Double Blind ◽  
Entire Study ◽  
Double Blind Placebo ◽  
And Control

Objective. Painful diabetic neuropathy (PDN) is a prevalent debilitating consequence of diabetes mellitus with lack of satisfactory therapeutic options. Methylcobalamin (MeCbl) is one of vitamin B12 analogs with known neurotrophic effects. We aimed to determine if MeCbl can relieve PDN. Materials and methods. This was a randomized (1:1) double-blind placebo-controlled trial involving PDN patients. Treatment and control group received daily 12.5 mg oral amitriptyline bid with either 500 µg of intravenous MeCbl or saline injection given on alternating days, respectively, for a 9-consecutive day period. PDN was assessed with douleur neuropathique 4 (DN4) questionnaire. Numeric pain rating scale (NPRS) was used to monitor pain intensity and treatment response. All investigators and patients were kept blinded throughout the study period. Outcomes. 42 patients, 21 on each arm had completed the study. The NPRS reduction can already be observed as early as day 2 post-intervention. Both the treatment and control group demonstrated sustained reduction of NPRS by almost one point per each time point of evaluation in the first three days (p<0.001). NPRS reduction remained until the end of the study period. The treatment group had a significantly lower NPRS score by 1.29 than that of the control group during the entire study period (95% CI -1.84 – -0.75; p < 0.001). Treatment group experienced significantly higher NPRS reduction when compared with control (4.19±1.54 vs. 2.1± 0.83; 95% CI 1.32-2.87; p < 0.001), i.e. 62.6% from baseline. Conclusions. MeCbl significantly and safely relieved PDN in a relatively rapid onset.

scholarly journals 154 Functioning in de Novo and Rollover Patients with Bipolar I Disorder Receiving Aripiprazole Once-monthly in a 52-Week, Open-label Study

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 298-299
Author(s):  
Jessica J Madera ◽  
Pedro Such ◽  
Maxine Chen ◽  
Ross A Baker
Keyword(s):  
Depressive Symptoms ◽  
Maintenance Treatment ◽  
Rating Scale ◽  
De Novo ◽  
Open Label ◽  
Safety Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Term Maintenance

Abstract:Introduction:Long-term maintenance treatment is essential in management of bipolar I disorder (BP-I) to achieve mood stability, prevent recurrence of mood episodes and improve functioning. Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting formulation of aripiprazole for maintenance treatment of BP-I. In a double-blind, placebo-controlled, randomized withdrawal study in adult patients with BP-I after a manic episode (NCT01567527), AOM 400 delayed time to and reduced rate of recurrence of mood episodes and was safe and well tolerated (1). In an open-label, long-term safety study (NCT01710709), AOM 400 was safe and effective as long-term maintenance treatment (2).Objective:To evaluate the effect of long-term AOM 400 maintenance treatment on manic and depressive symptoms in BP-I patients from the open-label, long term safety study.Methods:Manic and depressive symptoms were assessed post-hoc by analysis of change from study entry in the Young-Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and line item scores. The mean changes from baseline at last visit in YMRS and MADRS total scores, and single items were calculated using descriptive statistics, using last observation carried forward for total scores and observed cases for single items.Results:A total of 464 patients entered the maintenance phase: 379 were de novo and 85 were rollover patients who completed the double-blind, placebo-controlled withdrawal study. Overall, 63% (291/464) completed 52 weeks of open-label treatment. Mean YMRS and MADRS total scores were minimally changed from baseline (YMRS: 2.31, endpoint change -0.30; MADRS: 3.23, endpoint change +1.24) across the study in the total population.Conclusion:Patients entering an open-label safety study with stable manic and depressive symptoms maintained stability in both types of symptoms, as shown by minimal mean changes from baseline in YMRS and MADRS scores, suggesting that treatment with AOM 400 is effective in preventing re-emergence of both manic and depressive symptoms.Funding Acknowledgements:The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.

scholarly journals Clinical Study on the Prevention of Oxaliplatin-Induced Neurotoxicity with Guilongtongluofang: Results of a Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Yunfang Liu ◽  
Guangying Zhu ◽  
Li Han ◽  
Jie Liu ◽  
Ting Ma ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Rating Scale ◽  
Tumor Response ◽  
Controlled Trial ◽  
Control Group ◽  
Trial Group ◽  
Peripheral Neurotoxicity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Objective. Oxaliplatin-induced peripheral neurotoxicity continues to be a kind of frequent dose-limiting toxicity for many cancer patients. This study evaluated the preventive effects of Guilongtongluofang on peripheral neurotoxicity induced by oxaliplatin in patients with colorectal tumor.Patients and Methods. From May 2007 to May 2011, we conducted a randomized, double-blind, placebo-controlled trial. 120 patients of colorectal cancer treated with adjuvant oxaliplatin-based chemotherapy were randomly enrolled into the trial group and the control group. The trial group received Guilongtongluofang (at a dose of 200 mL once a day) from 3 days prior to chemotherapy. The control group received a placebo from 3 days prior to chemotherapy. Every 2-week cycle, neurotoxicity was evaluated using numeric rating scale for pain intensity and experienced relief. The primary endpoint was efficacy measurement which included oxaliplatin-induced neurotoxicity and tumor response. The differences of side effects between the two groups were also analyzed.Results. The percentage of grades 1-2 neurotoxicity was significantly lower in the trial group than that in the control group (13.3% versus 20.0%;P<0.05) after two cycles of treatment. The difference of the percentage of neurotoxicity between the two groups was significant after six cycles (51.7% versus 70.0%;P<0.05). Significant difference for the mean time to the development of grade 1+ neurotoxicity was found between the two groups (9.4 w in the trial group versus 6.5 w in the control group,P<0.05). The cumulative incidence of grade 1 or more sensory neurotoxicity was significantly lower in the trial group than that in the control group (P<0.05). No significant differences of tumor response rate were found between the two groups the trial group and the control group. No significant difference was found between the trial group and the control group (allP>0.05).Conclusion. This study provides evidence that Guilongtongluofang is a promising drug for the prevention of oxaliplatin-induced neurotoxicity in patients with colorectal cancer, and it does not reduce the efficacy of oxaliplatin.

scholarly journals Celecoxib added to mood stabilizer for treating acute mania: A randomized, double -blind, placebo-controlled trial

2020 ◽  
Author(s):  
Farhad Faridhosseini ◽  
Ali talaei ◽  
najmeh shahini ◽  
meysam poorgholami ◽  
mahbobeh eslamzadeh ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Mood Stabilizer ◽  
Acute Mania ◽  
Control Group ◽  
Double Blind ◽  
Exact Test ◽  
Double Blind Placebo ◽  
Inflammatory Processes

Abstract Background: Inflammatory processes in the brain contribute to the aetiopathogenesis of acute mania. Cyclooxygenase-2 (COX-2) inhibitors, such as celecoxib, reduce the production of pro-inflammatory cytokines. The purpose of the present investigation was to assess the efficacy of celecoxib in the treatment of ACUTE MANIA.Methods: We conducted double-blind, placebo-controlled trial at the Specialty in-patient Clinic of Ibne Sina Hospital [Mashhad University of Medical Sciences, Iran] during March 2014 to August 2014. The study involved 58 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for ACUTE MANIA screening to participate in the trial were used for the study. 23 patients were assigned to a study group and were given valprovate sodium 200 mg /BD plus celecoxib 400 mg/day (200 mg BID). The control group included 22 patients who were given valprovate sodium 200 mg /BD plus placebo. Patients were assessed by yung mania rating scale (YMRS) at baseline 0, after 9, 18, and 28 days after the medication started. Data were analyzed by using Statistical Package for Social Sciences (SPSS) 11.5., two-way repeated measures analysis of variance, Fisher’s exact test, and T-Test. P≤0.05 was considered to be statistically significant. Conclusion: This study suggested that celecoxib can be an effective adjuvant agent in management of patients with ACUTE MANIA and anti-inflammatory therapies should further be investigated in this patients.Trial registration: Iran clinical trial register: IRCT20200306046708N1 Registered on 2 October 2019.

scholarly journals 155 Symptom Stability in de Novo and Rollover Patients with Bipolar I Disorder Receiving Aripiprazole Once-monthly in a 52-Week, Open-label Study

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 299-299
Author(s):  
Jessica J Madera ◽  
Pedro Such ◽  
Maxine Chen ◽  
Ross A Baker
Keyword(s):  
Depressive Symptoms ◽  
Maintenance Treatment ◽  
Rating Scale ◽  
De Novo ◽  
Open Label ◽  
Safety Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Term Maintenance

Abstract:Introduction:Long-term maintenance treatment is essential in management of bipolar I disorder (BP-I) to achieve mood stability, prevent recurrence of mood episodes and improve functioning. Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting formulation of aripiprazole for maintenance treatment of BP-I. In a double-blind, placebo-controlled, randomized withdrawal study in adult patients with BP-I after a manic episode (NCT01567527), AOM 400 delayed time to and reduced rate of recurrence of mood episodes and was safe and well tolerated (1). In an open-label, long-term safety study (NCT01710709), AOM 400 was safe and effective as long-term maintenance treatment (2).Objective:To evaluate the effect of long-term AOM 400 maintenance treatment on manic and depressive symptoms in BP-I patients from the open-label, long term safety study.Methods:Manic and depressive symptoms were assessed post-hoc by analysis of change from study entry in the Young-Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and line item scores. The mean changes from baseline at last visit in YMRS and MADRS total scores, and single items were calculated using descriptive statistics, using last observation carried forward for total scores and observed cases for single items.Results:A total of 464 patients entered the maintenance phase: 379 were de novo and 85 were rollover patients who completed the double-blind, placebo-controlled withdrawal study. Overall, 63% (291/464) completed 52 weeks of open-label treatment. Mean YMRS and MADRS total scores were minimally changed from baseline (YMRS: 2.31, endpoint change -0.30; MADRS: 3.23, endpoint change +1.24) across the study in the total population.Conclusion:Patients entering an open-label safety study with stable manic and depressive symptoms maintained stability in both types of symptoms, as shown by minimal mean changes from baseline in YMRS and MADRS scores, suggesting that treatment with AOM 400 is effective in preventing re-emergence of both manic and depressive symptoms.Funding Acknowledgements:The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.

scholarly journals Efficacy of Crest Herbal Toothpaste in “Clearing Internal Heat”: A Randomized, Double-Blind Clinical Study

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Jia-Xu Chen ◽  
Yue-Yun Liu ◽  
Shao-Xian Wang ◽  
Xiao-Hong Li
Keyword(s):  
Rating Scale ◽  
Statistical Significance ◽  
Internal Heat ◽  
Control Group ◽  
Clinical Test ◽  
Double Blind ◽  
Intention To Treat ◽  
Group A ◽  
Group B ◽  
Control Group Group

Objective. Evaluation of the efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat.”Methods. This was a randomized, double-blind, controlled parallel design clinical test of a product that was already on the market. 72 subjects were randomly assigned to control group (group A with Colgate Herbal Salty Toothpaste) or treatment group (group B with Crest Herbal Crystal Toothpaste) with ratio of 1 : 2. Subjects were instructed to brush with 1g toothpaste for 2 minutes each time, 2 times per day in a 4-aweek test period; measurement with the rating scale on the efficacy of “clearing internal heat” for the herbal toothpaste was done at baseline, 2 weeks, and 4 weeks of toothpaste usage.Results. The rating scale on efficacy of “clearing internal heat” for the herbal toothpaste reveals that the primitive points of 72-case intention-to-treat (ITT) analysis and 67-case per-protocol (PP) analysis for subjects in group A and subjects in group B were found to be reduced progressively with statistical significance (P<0.05). The overall effective rates for group A and group B were, respectively, 62.50%, 56.25% (ITT) and 62.50%, 60.64% (PP). The statistical results indicated that the symptoms of fire-heat for both groups of subjects have been improved after application of toothpaste.Conclusion. The efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat” was confirmed by the trial as compared to Colgate Herbal Salty Toothpaste. And its efficacy was objectively evaluated by the rating scale on efficacy of “clearing internal heat.”

scholarly journals Celecoxib added to mood stabilizer for treating acute mania in bipolar disorder: A randomized, double -blind, placebo-controlled trial in IRAN

2021 ◽  
Author(s):  
Farhad Faridhosseini ◽  
Ali Talaei ◽  
Najmeh Shahini ◽  
Mahbobeh Eslamzadeh ◽  
Samira Ahrari ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Acute Mania ◽  
Control Group ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Valproate Sodium ◽  
Significant Difference

Abstract Background: Inflammatory processes in the brain contribute to the aetiopathogenesis of acute mania. Cyclooxygenase-2 (COX-2) inhibitors, such as Celecoxib, reduce the production of pro-inflammatory cytokines. The purpose of the present investigation was to assess the efficacy of Celecoxib in the treatment of acute mania.Methods: We conducted a double-blind, placebo-controlled trial at the Specialty in-patient Clinic of Ibn-e-Sina Hospital [Mashhad University of Medical Sciences, Iran] from March 2017 to August 2017. The study involved 58 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for acute mania screening to participate in the trial were used for the study. Twenty-three patients were assigned to a study group and were given Valproate Sodium 200 mg /BD plus Celecoxib 400 mg/day (200 mg BID). The control group included 22 patients who were given Valproate Sodium 200 mg /BD plus placebo. Patients were assessed by Young Mania Rating Scale (YMRS) at baseline 0, after 9, 18, and 28 days after the medication started. Data were analyzed by using Statistical Package for Social Sciences (SPSS) 11.5., two-way repeated measures analysis of variance, Fisher’s exact test, and T-Test. P≤0.05 was considered to be statistically significant.Results: A total of 58 patients were screened and 45 were randomized. Most of participations in celecoxib group were male (55%) and in placebo group were female (75%). There were no statistically significant differences between the groups regarding number of episode. sex, marital status, past medical history, past psychiatry history and family history P value ≥0.05. A significant difference was observed in the change of scores on Young Mania Rating Scale (YMRS) at week 4 as compared to the baseline in patient groups P: 0.04.Conclusion: This study suggested that Celecoxib can be an effective adjuvant agent in managing patients with acute mania and anti-inflammatory therapies should further be investigated in these patients.Trial registration: Iran clinical trial register: IRCT20200306046708N1

scholarly journals Efficacy and Safety of the Cudrania tricuspidata Extract on Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Multicenter Study

2021 ◽  
Vol 10 (22) ◽  
pp. 5323
Author(s):  
Jinyoung Shin ◽  
Tae-Hoon Oh ◽  
Joo-Yun Kim ◽  
Jae-Jung Shim ◽  
Jung-Lyoul Lee
Keyword(s):  
Functional Dyspepsia ◽  
Rating Scale ◽  
Gastrointestinal Symptoms ◽  
Controlled Study ◽  
Caffeine Intake ◽  
Control Group ◽  
Double Blind ◽  
Cudrania Tricuspidata ◽  
Double Blind Placebo ◽  
Folk Remedy

Cudrania tricuspidata is a folk remedy used to treat inflammation in patients with tumors or liver damage. This study investigated the efficacy of Cudrania tricuspidata extract (CTE) for relieving the symptoms of functional dyspepsia. In an 8-week, randomized, double-blind, placebo-controlled study, 100 adults with any condition featured in the Rome IV criteria and a Gastrointestinal Symptoms Scale (GIS) score ≥4 were randomly allocated to take either a placebo (maltodextrin) or a 50 mg CTE tablet, which equally included celluloses, magnesium stearate, and silicon dioxide, twice daily, 20 January 2020, and 3 August 2020. Among the 83 participants finally analyzed, the CTE group was associated with a significant reduction in the gastrointestinal symptom rating scale (day 0: 8.0 ± 5.2, day 28: 4.7 ± 3.9, and day 56: 2.3 ± 2.4, p < 0.001, respectively) in comparison with the control group (day 0: 8.1 ± 4.7, day 28: 7.8 ± 5.7, and day 56: 7.5 ± 6.6, p > 0.05) after adjusting for smoking, drinking, eating habits, stress levels, and caffeine intake. The CTE group resulted in significant improvements of GIS, Nepean Dyspepsia Index (Korean version), and functional dyspepsia-related quality of life over time. There were no different adverse events (p = 0.523). These findings suggest that CTE is safe and efficacious for alleviating gastrointestinal symptoms in patients with functional dyspepsia.

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