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

This study has been completed.

Study NCT00409708 Information provided by Novartis

First Received on December 8, 2006. Last Updated on April 19, 2011 History of Changes

Results First Received: December 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Attention Deficit Hyperactivity Disorder
Interventions:	Drug: Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy Behavioral: Behavior Therapy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ritalin LA Plus Behavior Therapy	10-60 mg/day
Behavior Therapy	0 mg/day Ritalin LA

Participant Flow for 2 periods

Period 1: Treatment

	Ritalin LA Plus Behavior Therapy	Behavior Therapy
STARTED	53 ^[1]	56
COMPLETED	38	39
NOT COMPLETED	15	17
Abnormal test procedure result(s)	1	0
Lack of Efficacy	0	1
Protocol Violation	6	2
Withdrawal by Subject	3	8
Lost to Follow-up	0	6
Administrative problems	5	0

[1]	A total of 142 participants were screened for the study but only 109 were randomized to treatment

Period 2: Washout

	Ritalin LA Plus Behavior Therapy	Behavior Therapy
STARTED	38	39
COMPLETED	17	29
NOT COMPLETED	21	10
Lack of Efficacy	9	1
Protocol Violation	0	1
Withdrawal by Subject	11	5
Lost to Follow-up	1	3

Baseline Characteristics

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Reporting Groups

	Description
Ritalin LA Plus Behavior Therapy	10-60 mg/day
Behavior Therapy	0 mg/day Ritalin LA

Baseline Measures

	Ritalin LA Plus Behavior Therapy	Behavior Therapy	Total
Number of Participants [units: participants]	52	52	104
Age [units: participants]
<=18 years	52	52	104
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	8.3 ± 1.75	8.5 ± 1.91	8.4 ± 1.83
Gender [units: participants]
Female	21	17	38
Male	31	35	66

Outcome Measures

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1. Primary:

The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12) [ Time Frame: baseline and at end of treatment (Week 12) ]

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2. Primary:

The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12) [ Time Frame: baseline and at end of treatment (Week 12) ]

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3. Secondary:

Number of Sister Chromatoid Exchanges Per Cell [ Time Frame: baseline and at end of treatment (Week 12) ]

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4. Secondary:

Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes [ Time Frame: End of treatment (Week 12) ]

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5. Secondary:

Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) [ Time Frame: Baseline to end of treatment (Week 12) ]

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6. Secondary:

Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I) [ Time Frame: From baseline to the end of treatment (Week 12) ]

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7. Secondary:

Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S) [ Time Frame: From baseline to the end of treatment (Week 12) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00409708 History of Changes
Other Study ID Numbers:	CRIT124D2201
Study First Received:	December 8, 2006
Results First Received:	December 6, 2010
Last Updated:	April 19, 2011
Health Authority:	United States: Food and Drug Administration