Bipolar Disorder. Mania episode
Conditions
Interventions
Intervention 1: Intervention group: Valproate 600-800 mg/day plus Celecoxib 400 mg/day for 6 weeks. Intervention 2: Control group: Valproate 600-800 mg/day plus placebo for 6 weeks.
Treatment - Drugs
Placebo
Intervention group: Valproate 600-800 mg/day plus Celecoxib 400 mg/day for 6 weeks
Control group: Valproate 600-800 mg/day plus placebo for 6 weeks
Sponsors
Tehran University of Medical Sciences
Vice chancellor for research, Kurdistan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: meeting the DSM-IV criteria for Bipolar Disorder; age between 18 and 65 years; a score of at least 20 points on the Young Mania Rating Scale; Exclusion criteria: hyper- or hypothyroidism; substance dependence(except for Nicotine); IQ lower than 70; history of allergy to Celecoxib; lactating and pregnant women; gastro-intestinal ulcer or hemorrhage; cerebrovascular hemorrhage; severe hepatic disease
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of mania. Timepoint: Baseline and weerks 1, 2, 4, 6. Method of measurement: by Young Mania Rating Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of extrapyramidal side effects. Timepoint: Baseline and weerks 1, 2, 4, 6. Method of measurement: By Extrapyramidal Symptom Rating Scale(ESRS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactProf. Shahin Akhondzadeh
Tehran University of Medical Sciences
Outcome results
None listed