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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201108027202N1

Enrollment

Registered

2011-09-06

Start date

2011-09-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder Manic/Mixed phase in Children & Adolescents. Manic episode

Interventions

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 Aripip

Treatment - Drugs

Placebo

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 dail

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 t

Eligibility

Sex/Gender

All

Age

10 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: hospitalized Patients, between 10 to 17 years old, diagnosis of BPD based on DSM-IV-TR Exclusion criteria: Hypersensitivity to Aripiprazole or Lithium, Severe Medical Conditions (cardiovascular disorders, hepatic, renal and thyroid dysfunctions & severe diabetes), Serious Neurological Disorders, Dehydration, Ketoacidosis, Pregnancy, Lactation, MR patients

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Efficacy. Timepoint: Baseline, 3 and 6 weeks after the treatment. Method of measurement: Young Mania Rating Scale, CGI-Improvement and CGAS Scales.	—

Secondary

Measure	Time frame
Changes in blood glucose level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: FBS Laboratory test.;Changes in Triglycerides Fasting level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: TG Laboratory test.;Changes in Total Cholesterol level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: Total Chol. Laboratory test.;Blood Cells Counting. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: CBC Laboratory test.;Changes in serum creatinine level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: Serum Cr. Laboratory test.;Changes in T4, TSH levels. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: Thyroid function test.;Weight changes. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: measuring weight by balance.;Other side effects of treatments. Timepoint: after 3 and 6 weeks of treatment. Method of measurement: Side Effect Check List.	—

Measure

Time frame

Changes in blood glucose level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: FBS Laboratory test.;Changes in Triglycerides Fasting level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: TG Laboratory test.;Changes in Total Cholesterol level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: Total Chol. Laboratory test.;Blood Cells Counting. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: CBC Laboratory test.;Changes in serum creatinine level. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: Serum Cr. Laboratory test.;Changes in T4, TSH levels. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: Thyroid function test.;Weight changes. Timepoint: Before Entering the Study and 6 Weeks after treatments. Method of measurement: measuring weight by balance.;Other side effects of treatments. Timepoint: after 3 and 6 weeks of treatment. Method of measurement: Side Effect Check List.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDoctor Padideh Ghaeli

Faculty of Pharmacy of Tehran University of Medical Scienses

pghaeli@sina.tums.ac.ir - mmppg@yahoo.com - massud.akbari@gmail.com+98 21 6695 4709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026