Health Condition 1: F913- Oppositional defiant disorder
Conditions
Interventions
Intervention1: Aripiprazole: Aripiprazole is a second-generation antipsychotic that acts as a partial agonist at dopamine D2 and serotonin
5HT1A receptors, and an antagonist at 5HT2A receptors. It is
Sponsors
Dr Yati Chandra Srivastava
Eligibility
Inclusion criteria
Inclusion criteria: Children and adolescents aged 6 16 years Diagnosis of ODD based on DSM-5 criteria. Consent from parents/guardians and assent from child (where applicable) Patients referred to and attending the Child and Adolescent Psychiatry Outpatient Department (OPD) of the Department of Psychiatry, King George s Medical University, Lucknow, will be included in the study. Children and adolescents aged 6 16 years with a diagnosis of Oppositional Defiant Disorder (ODD) as per DSM-5 criteria, confirmed using the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), will be enrolled after obtaining written informed consent from parents/guardians and assent from the participants. Only new patients who require pharmacological management, as decided by the consultant in charge, will be considered for inclusion. Baseline assessment will be carried out using K-SADS, Vanderbilt Assessment Scale, Clinical Global Impression-Severity (CGI-S), Affective Reactivity Index (ARI), Modified Overt Aggression Scale (MOAS), along with routine blood investigations. Aripiprazole tablets will be prescribed in a dose range of 2 5 mg/day, with titration up to a maximum of 15 mg/day as deemed appropriate by the treating clinician. Rescue medication in the form of trihexyphenidyl (2 6 mg/day) will be permitted in case of emergent side effects, and proper documentation of its use will be maintained. The contact details of the investigator will be provided to the caregivers for management of any emergent conditions. Follow-up assessments will be conducted at 2, 4, and 6 weeks, and the same scales will be re-administered at each visit to monitor response and adverse effects. Adherence will be assessed by verbal enquiry and pill count during each follow-up visit. All data will be systematically recorded, entered, and subjected to statistical analysis for the derivation of final results.
Exclusion criteria
Exclusion criteria: Presence of intellectual disability assessed clinically. Autism spectrum disorder or other major neurodevelopmental disorders (e.g. ADHD). History of seizure disorder or other major medical illness. Prior use of Aripiprazole in the last 4 weeks. Known hypersensitivity to aripiprazole. Children who are already undergoing behavioral therapy for the same.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement would be checked on NICHQ vanderbilt assessment scale, Affective reactivity index, modified overt aggression scale. more than 50% reduction in aggression would be drawn as improvement.Timepoint: 2 weeks, 4 weeks and 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactDr Yati Chandra Srivastava
King Georges Medical University
Outcome results
None listed