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

NCT00409708 | Completed Phase 2 Results

• 1 other identifier: CRIT124D2201
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder,; ADHD; Cytogenetic abnormalities,; extended-release methylphenidate,

Outcome Measures

Primary Outcomes (2)

• The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)

  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.

  baseline and at end of treatment (Week 12)

• The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)

  The number of micronuclei per 1000 binucleated cells was measured at Baseline ( n=34 , n=29 ) and at the end of treatment, Week 12 (n =34, n= 29), in blood cultured for 48 hours using a standard protocol.

  baseline and at end of treatment (Week 12)

Secondary Outcomes (5)

• Number of Sister Chromatoid Exchanges Per Cell

  baseline and at end of treatment (Week 12)

• Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes

  End of treatment (Week 12)

• Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)

  Baseline to end of treatment (Week 12)

• Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)

  From baseline to the end of treatment (Week 12)

• Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)

  From baseline to the end of treatment (Week 12)

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy

2

OTHER

Behavioral: Behavior Therapy

Interventions

Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy DRUG

Also known as: Ritalin LA

1

Behavior Therapy BEHAVIORAL

2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of both genders, 6-12 years old
• Written informed consent by the parent and the patient (over 7)
• Diagnosis of ADHD
• Age-appropriate cognitive functioning
• All patients who had at least one post-baseline cytogenetic assessment in the core study can enter the observation phase.

You may not qualify if:

• History of malignant neoplasm
• History of seizures (except childhood febrile seizures)
• Hyperthyroidism
• Concurrent medical condition which may interfere with study

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals Investigational site

Houston, Texas, 77007, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Chromosome Aberrations

Interventions

Methylphenidate; Behavior Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Last Updated: May 17, 2011
• Results First Posted: May 17, 2011

Record last verified: 2011-04

Locations

US (1)