Celecoxib adjunctive therapy for acute bipolar mania: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
Recent research has focused on the inflammatory cascade as a key culprit in the etiology of bipolar disorder. We hypothesized that celecoxib, via its anti-inflammatory properties, may have a therapeutic role in mood disorder.


METHODS
Forty-six inpatients with the diagnosis of acute bipolar mania without psychotic features participated in a parallel, randomized, double-blind, placebo-controlled trial, and underwent six weeks of treatment with either celecoxib (400 mg daily) or placebo as an adjunctive treatment to sodium valproate. Patients were evaluated using the Young Mania Rating Scale (YMRS) and Hamilton Depression Rating Scale (HDRS). The primary outcome measure with respect to efficacy was the mean decrease in YMRS score from baseline to the study endpoint, which was compared between the two groups.


RESULTS
A significant difference was observed in the change in YMRS scores on Day 42 compared to baseline in the two groups (p < 0.001). The changes at the endpoint compared to baseline were -29.78 ± 21.78 (mean ± standard deviation) and -21.78 ± 7.16 for the celecoxib and placebo groups, respectively. A significantly higher remission rate was observed in the celecoxib group (87.0%) than the placebo group (43.5%) at Week 6 (p = 0.005). General linear model repeated measures demonstrated a significant effect for the time × treatment interaction on the YMRS scores [F(2.27,99.98) = 6.67, p = 0.001].


CONCLUSIONS
Celecoxib is an effective adjuvant therapy in the treatment of manic episodes (without psychotic features) of bipolar mood disorder. The mood-stabilizing role of the drug might be mediated via its action on the inflammatory cascade.
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Somayeh
S
Arabzadeh
Qods Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Niusha
N
Ameli
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Atefeh
A
Zeinoddini
Qods Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Farzin
F
Rezaei
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Mehdi
M
Farokhnia
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Payam
P
Mohammadinejad
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.
Ali
A
Ghaleiha
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Shahin
S
Akhondzadeh
D000328:Adult; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology; D000068579:Celecoxib / Q000008:administration & dosage*; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy*; D008297:Male; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage* / Q000627:therapeutic use
D052246:Cyclooxygenase 2 Inhibitors; D014635:Valproic Acid; D000068579:Celecoxib
COX-2 inhibitor; adjunctive therapy; celecoxib; clinical trial; inflammation; mania