A clinical trial to study the effects of IP-020 in the treatment of Attention deficit hyperactivity disorder.

Phase 3

• Registration Number: CTRI/2010/091/001453
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Male or Female patients aged 6 to 18.
2.Patients diagnosed with ADHD by DSM-IV for ADHD criteria will be enrolled for the study.
3.Patients whose parents and/or guardians provide written informed consent. (Parents and/or guardians signature is mandatory).

Exclusion Criteria

1.Patients who has concurrent of history of a significant medical or psychiatric illness (schizophrenia, bipolar disorder or autism) that could have interfered with study participation or assessments.
2.Patients who has marked anxiety, tension and agitation.
3.Patients with Cardiovascular disease or problem.
4.Patients with Glaucoma.
5.Patients with a known or suspected history of drug or alcohol abuse or dependence within the previous 6 months.
6.Patients have a history of poor response or intolerance of CNS stimulant viz. amphetamines salts or dextro-amphetamine salts.
7.Patients who are taking Clonidine or other centrally-acting alpha-2-agonists.
8.Patinets who are hypersensitive to Mehylphenidate.
9.Patients with clinically significant abnormal Vital Signs, judged by investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified