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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.
This study will determine whether the administration of extended-release methylphenidate in treatment-naïve children with Attention Deficit Hyperactivity Disorder (ADHD) affects the frequency of chromosomal abnormalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
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| 2 | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sister Chromatoid Exchanges Per Cell | Blood collected at baseline (n=20, n=14) and at the end of treatment, Week 12, (n= 20, n= 14) was cultured for 48 hours using a standard protocol. Giemsa staining and/or fluorescent in situ hybridization (FISH) chromosome painting was done on the cells in metaphase and the number of chromatoid exchanges per cell was recorded by blinded raters. | baseline and at end of treatment (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals Investigational site | Houston | Texas | 77007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ritalin LA Plus Behavior Therapy | 10-60 mg/day |
| FG001 | Behavior Therapy | 0 mg/day Ritalin LA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
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| Behavior Therapy |
| Behavioral |
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| Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes | Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics. | 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) | Parents completed the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) consisting of the ADHD Index (12 items) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)( 18 items). Parents rated their child's behavior of the previous week from a list of common problems. When asked "How much of a problem has this been in the last week?" parents selected 0 = none, not at all, seldom, or very infrequently; 3 = very much true, or it occurs very often or frequently; or 1 or 2 for ratings in between. A score of 50 is considered normal and more than 70 markedly atypical. | 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) | The Clinical Global Impression scale (CGI-I) is a clinician-rated instrument designed to assess the overall change of illness relative to baseline. The CGI-I consists of 7 ratings as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I assessments are relative to the patient's status at the Baseline visit. | 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) | The Clinical Global Impression scale (CGI-S) is a clinician-rated instrument designed to assess the severity of illness. The CGI-S rating indicates illness severity at each time-point on a scale as follows: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. CGI-S assessments are relative to the patient's status at the Baseline visit. | From baseline to the end of treatment (Week 12) |
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| NOT COMPLETED |
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| Washout |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ritalin LA Plus Behavior Therapy | 10-60 mg/day |
| BG001 | Behavior Therapy | 0 mg/day Ritalin LA |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Per-Protocol-1 (PP1) population: The PP1 population consisted of all patients who were randomized and provided cytogenetic data for at least one of the primary endpoints at baseline and at the Week 12 evaluation. | Posted | Mean | Standard Deviation | number of abnormalities | baseline and at end of treatment (Week 12) |
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| Secondary | Number of Sister Chromatoid Exchanges Per Cell | Blood collected at baseline (n=20, n=14) and at the end of treatment, Week 12, (n= 20, n= 14) was cultured for 48 hours using a standard protocol. Giemsa staining and/or fluorescent in situ hybridization (FISH) chromosome painting was done on the cells in metaphase and the number of chromatoid exchanges per cell was recorded by blinded raters. | Per-Protocol-2 population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | number of sister chromatoid exchanges | baseline and at end of treatment (Week 12) |
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| Secondary | Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes | Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics. | Posted | Number | Number | End of treatment (Week 12) |
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| Secondary | Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) | Parents completed the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) consisting of the ADHD Index (12 items) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)( 18 items). Parents rated their child's behavior of the previous week from a list of common problems. When asked "How much of a problem has this been in the last week?" parents selected 0 = none, not at all, seldom, or very infrequently; 3 = very much true, or it occurs very often or frequently; or 1 or 2 for ratings in between. A score of 50 is considered normal and more than 70 markedly atypical. | Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a rating scale | Baseline to end of treatment (Week 12) |
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| Secondary | Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I) | The Clinical Global Impression scale (CGI-I) is a clinician-rated instrument designed to assess the overall change of illness relative to baseline. The CGI-I consists of 7 ratings as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I assessments are relative to the patient's status at the Baseline visit. | Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a rating scale | From baseline to the end of treatment (Week 12) |
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| 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) | The Clinical Global Impression scale (CGI-S) is a clinician-rated instrument designed to assess the severity of illness. The CGI-S rating indicates illness severity at each time-point on a scale as follows: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. CGI-S assessments are relative to the patient's status at the Baseline visit. | Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a rating scale | From baseline to the end of treatment (Week 12) |
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| Primary | 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. | Posted | Mean | Standard Deviation | number of micronuclei per 1000 binucleat | baseline and at end of treatment (Week 12) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ritalin+Behavior | Ritalin+Behavior | 0 | 52 | 28 | 52 | ||
| EG001 | Behavior | Behavior | 0 | 52 | 13 | 52 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MEDDRA 11.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
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| Initial Insomnia | Psychiatric disorders | MEDDRA 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MEDDRA 11.0 | Systematic Assessment |
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| Tearfulness | Psychiatric disorders | MEDDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.0 | Systematic Assessment |
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Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D002869 | Chromosome Aberrations |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| >=65 years |
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| Male |
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