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NCT00409708 · ClinicalTrials.gov registry record · Phase 2

Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 2 study, sponsored by Novartis.

Completed
Registry status
Phase 2
Development phase
142
Enrollment target

NCT00409708: Completed Phase 2 study, sponsored by Novartis.

NCT00409708 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 142 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00409708, a Phase 2 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 2
Development phase
142 participants
Enrollment target

Study Summary

This study will assess the frequency of chromosomal abnormalities measured in circulating lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD) treated for 3 months with either extended release methylphenidate or behavioral therapy.

Primary Outcome

The number of chromosomal aberrations per 100 cells excluding gaps at Baseline (n=33, n=32) and at Week 12 (n=33, n=32) was counted in blood samples cultured for 48 hours using a standard protocol. The types of abnormalities included translocations (reciprocal and non-reciprocal), insertions, dicentrics, fragments, inversions, chromatid exchanges (quadriradials and triradials), breaks, and other unusual observations, eg, aneuploidy, tetraploidy or endoreduplication.

Interventions

  • BEHAVIORAL Behavior Therapy
  • DRUG Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2006-11
Phase Phase 2
Novartis

265 total trials

What the finished NCT00409708 record still lists

NCT00409708 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Behavior Therapy is the first listed.

NCT00409708 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00409708 about?

NCT00409708 is a clinical study titled "Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)". This study will assess the frequency of chromosomal abnormalities measured in circulating lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD) treated for 3 months with either extended release methylphenidate or behavioral therapy.

What is the current status of trial NCT00409708?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2006-11.

What interventions are being tested in trial NCT00409708?

The interventions under investigation include: Behavior Therapy (BEHAVIORAL), Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy (DRUG).

Who is sponsoring clinical trial NCT00409708?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00409708's enrollment target sits among peer trials

142 507th of 2000 higher than 1,491 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00409708, the US trial registry maintained by the National Library of Medicine. NCT00409708 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.