Health Condition 1: F311- Bipolar disorder, current episodemanic without psychotic features
Conditions
Interventions
Intervention1: CELECOXIB: 200 MG BD, ORAL FOR 6 WEEKS
Control Intervention1: PLACEBO: BD, ORAL FOR 6 WEEKS
Sponsors
SUBHANSHU KUMAR
Eligibility
Inclusion criteria
Inclusion criteria: WRITTEN INFORMED CONSENT FROM THE PATIENT OR INFORMANT, BIPOLAR TYPE 1 DISORDER CURRENT EPISODE MANIC WITHOUT PSYCHOTIC SYMPTOMS WITH HISTORY OF AT LEAST 2 PRIOR MANIC EPISODES NOT TAKIG ANY TREATMENT FOR ATLEAST 2 MONTHS, YMRS MORE THAN OR EQUAL TO 20
Exclusion criteria
Exclusion criteria: Patient with diagnosis of any psychotic disorder, a history of rapid cycling bipolar disorder, or a primary diagnosis other than bipolar disorder, Patients with history of GI bleed, CNS bleed, cardiac failure, coronary artery bypass graft, hepatitis, severe hepatic impairment, renal issues, or any other contraindication for celecoxib administration, Presence of any other medical condition such as hypo- or hyperthyroidism, cardiac conduction abnormalities, a serious threat to suicide, Substance dependance with the exception of nicotine or caffeine, Pregnancy or breast feeding, Sensitivity to any drugs used in present study,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Evaluate the Efficacy of Celecoxib as An Add-On to Sodium Valproate in Reducing Manic Symptoms in Patients with Bipolar Type 1 Disorder, current episode manic, without psychotic symptoms. Timepoint: To Evaluate the Efficacy of Celecoxib as An Add-On to Sodium Valproate in Reducing Manic Symptoms in Patients with Bipolar Type 1 Disorder, current episode manic, without psychotic symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess Safety and Tolerability of Celecoxib and to Observe the Time to Clinical Response in The Celecoxib Group Compared to Placebo. Timepoint: Baseline 1 week 2 weeks 4 weeks 6 weeks | — |
Countries
India
Contacts
Public ContactDR BANDNA GUPTA
KING GEORGE MEDICAL UNIVERSITY
Outcome results
None listed