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

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

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

10.21203/rs.3.rs-20099/v1 ◽

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.

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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/541217 ◽

2013 ◽

Vol 2013 ◽

pp. 1-7 ◽

Cited By ~ 10

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.

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900023075 ◽

2005 ◽

Vol 10 (6) ◽

pp. 3-5

Author(s):

Richard H. Weisler

Keyword(s):

Extended Release ◽

Rating Scale ◽

Controlled Trial ◽

Controlled Study ◽

Mixed States ◽

Open Label ◽

Young Mania ◽

Double Blind ◽

Double Blind Placebo ◽

Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900024500 ◽

2005 ◽

Vol 10 (S1) ◽

pp. 3-5

Author(s):

Richard H. Weisler

Keyword(s):

Extended Release ◽

Rating Scale ◽

Controlled Trial ◽

Controlled Study ◽

Mixed States ◽

Open Label ◽

Young Mania ◽

Double Blind ◽

Double Blind Placebo ◽

Bipolar Patients

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Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n5p67 ◽

2016 ◽

Vol 9 (5) ◽

pp. 67

Author(s):

Mansoureh Mirzadeh ◽

Najmeh Shahini ◽

Masoud Kashani Lotf Abadi ◽

Maryam Tavakoli ◽

Arash Javanbakht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Function ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

P Value ◽

Double Blind ◽

Randomized Controlled ◽

Significant Difference ◽

Schizophrenic Patients

Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients. This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2nd, 7th, 14th, 28th. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28th compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor p value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05. Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.

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Effectiveness of a Snoezelen Room on Fear, Anxiety, and Satisfaction of Nulliparous Women: A Randomized Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.89168 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Mariyam Momeni ◽

Mansoureh Jamshidimanesh ◽

Hadi Ranjbar

Keyword(s):

Repeated Measures ◽

Rating Scale ◽

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Control Group ◽

Chi Square ◽

Nulliparous Women ◽

Significant Difference ◽

Interventional Group

Background: Pregnancy and childbirth are natural phenomena in a women’s life, associated with stress and anxiety, leading to adverse effects in the mother and fetus. Using complementary medicine, such as aromatherapy, music, light radiation, and aquariums in an environment that engage a person’s multiple senses can make mothers relax through mental deviations. Objectives: The aim of this study was to evaluate the effects of a Snoezelen room on fear, anxiety, and satisfaction of childbirth’s nulliparous women. Methods: This randomized clinical trial was carried out on 130 eligible women in a selected hospital affiliated to the Iran University of Medical Sciences in Tehran. One hundred thirty women were randomly assigned to the intervention (n = 65) and control (n = 65) groups using six modes blocks using the convenient sampling method. The delivery room was designed to distract women’s minds in the intervention group. Data were collected using a demographic characteristics form, Harman’s Childbirth Attitude questionnaire (CAQ), Visual Analogue scale (VAS) to measure childbirth anxiety, and the Mackey Childbirth Satisfaction Rating scale. Data were analyzed by SPSS version 16 using independent t-test, repeated measures analysis of variance, and Bonferroni and chi-square tests. Results: The results showed a significant reduction in fear in the active phase and postpartum in the intervention group compared with the control group (P < 0.001 and P < 0.001, respectively). Anxiety showed a significant difference and was lower at dilatation of 6 to 7 and 7 to 8 cm, and after childbirth in the interventional group. The satisfaction of childbirth significantly increased in the interventional group (P < 0.001). Conclusions: These results confirmed the importance of a Snoezelen room in the childbirth of nulliparous women, which can promote vaginal childbirth.

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

Romanian Journal of Neurology ◽

10.37897/rjn.2021.3.12 ◽

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.

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Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Mania or Mixed Feature Bipolar I Disorder: A Randomized Double-Blind Clinical Trial Study

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.90106 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Mercedeh Samiei ◽

Zahra Sepehrifar ◽

Reza Daneshmand ◽

Gita Sadighi

Keyword(s):

Sodium Valproate ◽

Rating Scale ◽

Maximum Level ◽

Acute Mania ◽

Therapeutic Effects ◽

Young Mania ◽

Double Blind ◽

Duration Of Symptoms ◽

Bipolar I Disorder ◽

Significant Difference

Background: Acute mania causes many problems for the patient and others. Therefore, it is very important to eliminate the symptoms quickly. Objectives: The present study made the individual comparison of the therapeutic effects of sodium valproate combined with quetiapine or haloperidol as an add-on among patients with bipolar I disorder experiencing an episode of mania or mixed feature admitted to a Psychiatric Center in Tehran. Methods: The present study was a double-blind clinical randomized trial conducted on 36 patients. All patients were investigated by the Young Mania Rating Scale (YMRS). The study lasted six weeks in total (after raising drug dosage to the maximum level). We prescribed sodium valproate 15 mg/kg plus quetiapine 500 mg daily in one group and sodium valproate 15 mg/kg plus haloperidol 10 mg daily in the other group. In addition, an equivalent dosage of quetiapine and haloperidol was prescribed. This study used different data analysis methods such as Paired t test, ANOVA, and chi-square test. Results: The YMRS scores did not show any statistically significant difference between quetiapine and haloperidol receiving groups (P > 0.05). Conclusions: This paper argued that a combination of sodium valproate with either quetiapine or haloperidol could be effective in the management of acute mania or mixed bipolar I disorder to reduce the severity and duration of symptoms, although there was no statistically significant difference between the efficacy of these two pharmacological therapies.

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A Double-Blind, Placebo-controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

European Psychiatry ◽

10.1016/s0924-9338(09)70809-0 ◽

2009 ◽

Vol 24 (S1) ◽

pp. 1-1

Author(s):

J. Houston ◽

M. Tohen ◽

E. Degenhardt ◽

H. Jamal ◽

L. Liu ◽

...

Keyword(s):

Rating Scale ◽

Controlled Trial ◽

Blood Levels ◽

Young Mania ◽

Double Blind ◽

Mixed Episode ◽

Bipolar I Disorder ◽

Double Blind Placebo ◽

Concomitant Medications ◽

Unique Study

Aims:This unique study of treatment of the mixed state of bipolar I disorder using simultaneous depression and mania response criteria compared divalproex monotherapy versus olanzapine augmentation in a 6-week, randomized, double-blind trial.Methods:Patients (age 18-60 years) with 14-28 days of divalproex monotherapy (blood levels of 75-125 μg/mL) were randomized to augmentation with olanzapine 5-20 mg/day or placebo. Data collected included: Hamilton Depression Rating Scale (HDRS), Young Mania Rating Scale (YMRS), Clinical Global Impression for Bipolar Illness (CGI-BP), hospitalizations, concomitant medications, and adverse events (AEs). Primary co-objectives were comparisons of baseline to endpoint changes in HDRS and YMRS. Secondary objectives included comparisons of times to onset (25% reduction) and response (50% reduction) in both HDRS and YMRS, change in CGI-BP, hospitalizations, and safety.Results:Patients were 59% female, 51% Caucasian, 33% African American, and 14% Hispanic with mean standard deviation (SD) HDRS and YMRS scores of 22.2 (4.5) and 20.9 (4.4). Mean standard error (SE) score changes for the olanzapine (n=100) or placebo (n=101) arms, respectively, were: HDRS, -9.37 (.55) and -7.69 (.54), p=.022; YMRS, -10.15 (.44) and -7.68 (.44), p< .001; and CGI-BP, -1.34 (.11) and -1.06 (.11), p=.056. Times-to-onset (median 7 vs 14 days) and response (median 25 vs 49 days) were significantly shorter for olanzapine augmentation. One olanzapine patient required hospitalization (p=1.0). Treatment-emergent AEs were consistent with previously-published rates.Conclusion:Six-week olanzapine treatment augmentation was associated with greater and earlier reduction of manic and depressive symptoms in mixed episode patients on divalproex treatment.

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A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Acidogenic Potential of Dental Biofilms through a Tablet Containing Weissella cibaria CMU

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18094674 ◽

2021 ◽

Vol 18 (9) ◽

pp. 4674

Author(s):

Mi-Sun Kang ◽

Dong-Suk Lee ◽

Myoungsuk Kim ◽

Seung-Ah Lee ◽

Seoul-Hee Nam

Keyword(s):

Dental Caries ◽

Oral Cavity ◽

Dental Plaque ◽

Controlled Trial ◽

Control Group ◽

Double Blind ◽

Oral Flora ◽

Double Blind Placebo ◽

Weissella Cibaria ◽

Significant Difference

The possibility of preventing dental caries by taking probiotic bacterium Weissella cibaria (W. cibaria) CMU tablets to alter the pH of the dental plaque in the oral cavity was evaluated. A randomized, double-blind, placebo-controlled trial was performed on adults aged 20 years or older with 20 or more natural teeth. Ninety-two people underwent dental scaling before being randomly assigned to the experimental group (n = 49) or the control group (n = 43). Depending on the group they belonged to, W. cibaria CMU or the placebo was administered to them once daily for 8 weeks before bedtime. Twenty-four subjects were later excluded from the study because the week 8 dosing was not smoothly performed, for a final subject count of 68. The Cariview test was used to evaluate the amount of acid produced by the dental plaque to assess the risk of caries. The results showed that although there was no significant difference between the results of the two groups, the intake of the W. cibaria CMU tablets eliminated the risk of developing dental caries from acid production in the oral flora because the W. cibaria colonizes and lives in the dental plaque and the oral cavity and suppresses acids.

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