IRCT201108027202N1 IRCT 2011-09-06 Tehran University of Medical Sciences Effect of Adding Aripiprazole to Li Therapy in Children & Adolescents with BPD Comparing the efficacy and side effects of concurrent use of aripiprazole versus placebo with lithium in pediatric patients with acute manic/mixed episodes of bipolar disorder 2011-09-01 anticipated 40 Complete https://irct.ir/trial/7624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Bipolar Disorder Manic/Mixed phase in Children & Adolescents. Intervention 1: Intervention group: day 1 to 3: Lithium with usual dose (300mg TDS or QID po) +2.5mg Aripiprazole once daily po - day 3 to 5: Lithium with usual dose (300mg TDS or QID po) + 5mg Aripiprazole once daily po - day 5 to 7: Lithium with usual dose (300mg TDS or QID po) + 10mg Aripiprazole once daily po - day 7 to the end of Study: Lithium with usual dose (300mg TDS or QID po) + 15mg Aripiprazole once daily po - unless dose adjustments required. The patients will receive Lorazepam po PRN or Halopridol Inj PRN if needed. Intervention 2: Control Group: day 1 to 3: Lithium with usual dose (300mg TDS or QID po) + 2.5mg Placebo once daily po - day 3 to 5: Lithium with usual dose (300mg TDS or QID po) + 5mg Placebo once daily po - day 5 to 7: Lithium with usual dose (300mg TDS or QID po) + 10mg Placebo once daily po – day 7 to the end of the study: Lithium with usual dose (300mg TDS or QID po) + 15mg Placebo once daily po -unless dose adjustments required. The patients will receive Lorazepam po PRN or Halopridol Inj PRN if needed.