Does celecoxib with sodium valproate have an augmentation effect on acute mania in bipolar disorder? A double-blind controlled clinical trial in Iran.

Inflammatory processes in the brain play a role in acute mania etiopathogenesis. There is little evidence indicating the efficacy of celecoxib adjuvant therapy in treatmenting of manic episodes of bipolar disorder. Therefore, this clinical trial aimed to assess the celecoxib effect on treating acute mania. In a double-blind, placebo-controlled trial, 58 patients meeting the criteria for acute mania were enrolled. After considering eligibility, 45 patients were included in the study and randomly divided into two groups. The first group (23 patients) received sodium valproate 400 mg/day along with celecoxib 400 mg/day, and the second group (22 patients) received sodium valproate 400 mg/day and a placebo. The subjects were evaluated by the Young Mania Rating Scale (YMRS) at the beginning of the study and 9, 18, and 28 days following the initiation of the medication. Evaluation of baseline factors indicated a significant difference in age ( P = 0.01) and psychiatric history ( P = 0.02) between the two groups. However, other factors were similar between groups ( P ≥ 0.05). Comparing the YMRS score between celecoxib and placebo groups revealed no significant difference on days 0, 9, 18, and 28. However, the YMRS score at the end of the study decreased by 16.05 ± 7.65 in the intervention group ( P < 0.001) and 12.50 ± 5.98 in controls ( P < 0.001) compared to the baseline, the trend of change was not significant between the two groups during the time of the study ( F = 0.38; P = 0.84). Although celecoxib adjuvant therapy indicated no considerable side effects, a longer treatment duration may be needed to detect its beneficial effects for treating acute mania in bipolar patients. Trial registration: Iran clinical trial register: IRCT20200306046708N1.

Effectiveness of Psychoeducational Group Training on Quality of Life and Recurrence of Patients with Bipolar Disorder.

Objective: Bipolar disorder (BD) is a disabling psychiatric disorder with frequent recurrences. Besides pharmacotherapy, psychoeducation could be helpful in reducing symptoms as well as recurrence of this disorder, leading to improvement of patients' quality of life. This study aimed at investigating the effectiveness of a culturally adjusted structured program for training Iranian BD patients. Method: In a 6-month course (spring and summer 2014), 24 BD patients, visiting the outpatient clinic of Ibn-Sina Hospital in Mashhad and experiencing euthymic phase, were allocated in to 2 groups of intervention and control. The intervention group received 8 sessions of psychoeducation in four weeks. Patients in the control group received the usual treatment. The patients were evaluated with Hamilton Depression Rating Scale, Young Mania Rating Scale, and Short Form 36 before the intervention and 4 weeks later, and the results were compared using independent t test. The patients were reexamined after 6 months for recurrence, hospitalization, treatment adherence, and visiting a psychiatrist, and were compared with patients in the control groups. Results: There was a significant difference in the intervention group in improvement in quality of life before and after treatment (p<0.003). In addition, the difference was significant between the 2 groups in the number of recurrence (p<0.001) and hospitalization (p<0.000) in 6 months. Conclusion: In addition to pharmacotherapy, psychoeducation of patients with BD can improve their quality of life and decrease the risk of disorder recurrence.

Tamoxifen: A Protein Kinase C Inhibitor to Treat Mania: A Systematic Review and Meta-Analysis of Randomized, Placebo-Controlled Trials.

OBJECTIVE: The aim of this study was to conduct a systematic review of literature to retrieve all randomized controlled trials that evaluated the efficacy of tamoxifen on manic mood episodes and meta-analyze their quantitative results. METHODS: Four electronic databases were systematically searched from their inception to March 2014: PubMed, Cochrane Library (Cochrane Central Register of Controlled Trials), Scopus, and PsychINFO. Pooled difference in means of changes in mania scores and pooled odds ratio of treatment response (for tamoxifen monotherapy) were calculated as the main effect size. A random effects model was used to pool the data across studies. Quantitative syntheses were expressed by forest plots. RESULTS: Five randomized controlled trials (3 adjunct trials and 2 monotherapy trials) were included. Regarding adjunct tamoxifen, the standardized difference in mean of mania score changes in tamoxifen arm as compared with control arm was 0.669 (95% confidence interval [CI], 0.15-1.189; P = 0.012). Regarding monotherapy, the pooled difference in means of mania score changes in the tamoxifen arm as compared with the placebo arm was 22.09 (95% CI, 20.98-23.192; P < 0.000000001). Pooled odds ratio of response to treatment was 15.36 (95% CI, 2.99-78.73; P = 0.001) in the tamoxifen group as compared with the placebo group. CONCLUSIONS: Tamoxifen can be considered an effective treatment for manic bipolar patients. Making a conclusion regarding the efficacy and safety for longer periods warrants further studies with a larger sample size and longer follow-up duration.

Celecoxib: a new augmentation strategy for depressive mood episodes. A systematic review and meta-analysis of randomized placebo-controlled trials.

OBJECTIVE: The aim of this research was to perform a systematic review to identify all randomized controlled trials (RCTs) evaluating the efficacy and safety of add-on celecoxib for treatment of depressive mood episodes. METHODS: Four electronic databases were systematically searched from their inception to 8 August 2013: PubMed, Cochrane Library (Cochrane Central Register of Controlled Trials), Scopus, and PsychINFO. Pooled difference in means of Hamilton Depression Rating Scale score, pooled odds ratio (OR) of treatment response, and pooled OR of remission were calculated as the main effect size. A random-effects model was used to pool the data across studies. RESULTS: Five RCTs (four unipolar depression studies and one bipolar depression study) were included in the systematic review for qualitative data synthesis. Moreover, quantitative results of four RCTs (unipolar depression studies) were meta-analyzed. The add-on celecoxib group had a statistically significant decrease in means of the Hamilton Depression Rating Scale score at week 4 (pooled difference in means=3.3, 95%CI [1.2-5.3], p=0.002) and week 6 (pooled difference in means=3.43, 95%CI [1.9-4.9], p<0.0001). The add-on celecoxib group also showed higher response (pooled OR=6.6, 95%CI [2.5-17], p<0.0001) and remission rates (pooled OR=6.6, 95%CI [2.7-15.9], p<0.0001) compared with the placebo group. CONCLUSIONS: Celecoxib can be considered as an effective add-on treatment for unipolar depressive patients. Making conclusion regarding the efficacy and safety for longer duration warrants further studies with a larger sample size and longer follow-up duration.