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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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In this study the investigators will measure the functional brain activity of adult Attention Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype, during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic effect of MPH treatment on cognitive functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylphenidate, non-retard | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate, non-retard | Drug | Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Activation | Functional brain activity in right Superior Frontal Gyrus (SFG) during the working memory task post treatment as measured by fMRI. For each participant and conditions the estimated parameters are metric, and can be further analysed with ANOVAs or t-tests. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychology | Accuracy for the working memory paradigm at post. Accuracy was defined as the ratio of correct responses (correctly pressed and correctly not pressed) to total number of stimuli. Higher values indicate better perfromance.The theoretical range goes from 0 to 1. | 6 weeks |
| ADHD Core Symptoms: Measured by Conners Adult ADHD Rating Scales (CAARS), Inattention Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Psychiatrie, Psychosomatics and Psychotherapy | Würzburg | Germany |
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Study Start: May 2011 Primary Completion: December 2012 Study Completion: March 2013 Wuerzburg University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate, Non-retard | Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition. |
| FG001 | Control: Placebo | For placebo treatment the same procedure was applied like in the verum condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate, Non-retard | Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Brain Activation | Functional brain activity in right Superior Frontal Gyrus (SFG) during the working memory task post treatment as measured by fMRI. For each participant and conditions the estimated parameters are metric, and can be further analysed with ANOVAs or t-tests. | lost of data due to fmri specific issues | Posted | Mean | Standard Error | Beta weights of contrast | 6 weeks |
|
through study completion at day 70
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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 | Methylphenidate, Non-retard | Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. M. Herrmann | Universitätsklinikum Würzburg | 093120176650 | Herrmann_m@ukw.de |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug |
|
Changes in CAARS scale ( T-values, 50 indicates the population mean with a standard deviation of 10) from pre to post. Higher T values indicate higher symptoms. T-score over 60 indicates clinically relevant ADHS symptoms More negative values of the difference indicate higher symptom reduction, therefore a better outcome. Range of T-values for pre and post measurements between 35 and 90, potential range for differences -55 to +55 |
| 6 weeks |
| BG001 | Control: Placebo | For placebo treatment the same procedure was applied like in the verum condition |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control: Placebo | For placebo treatment the same procedure was applied like in the verum condition |
|
|
|
| Secondary | Neuropsychology | Accuracy for the working memory paradigm at post. Accuracy was defined as the ratio of correct responses (correctly pressed and correctly not pressed) to total number of stimuli. Higher values indicate better perfromance.The theoretical range goes from 0 to 1. | Posted | Mean | Standard Deviation | accuracy index | 6 weeks |
|
|
|
|
| Secondary | ADHD Core Symptoms: Measured by Conners Adult ADHD Rating Scales (CAARS), Inattention Scale | Changes in CAARS scale ( T-values, 50 indicates the population mean with a standard deviation of 10) from pre to post. Higher T values indicate higher symptoms. T-score over 60 indicates clinically relevant ADHS symptoms More negative values of the difference indicate higher symptom reduction, therefore a better outcome. Range of T-values for pre and post measurements between 35 and 90, potential range for differences -55 to +55 | Posted | Mean | Standard Error | T-score | 6 weeks |
|
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| 18 |
| 19 |
| EG001 | Control: Placebo | For placebo treatment the same procedure was applied like in the verum condition | 0 | 16 | 0 | 16 | 10 | 16 |
| Therapeutic apical closure | Surgical and medical procedures | SNOMED CT | Systematic Assessment |
|
| Labile blood pressure | Cardiac disorders | SNOMED CT | Systematic Assessment |
|
| Palpitations | Cardiac disorders | SNOMED CT | Systematic Assessment |
|
| Pain in throat | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment |
|
| Dizziness postural | Ear and labyrinth disorders | SNOMED CT | Systematic Assessment |
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| Sudden hearing loss | Ear and labyrinth disorders | SNOMED CT | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | SNOMED CT | Systematic Assessment |
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| Feeling agitated | Psychiatric disorders | SNOMED CT | Systematic Assessment |
|
| Difficulty sleeping | Psychiatric disorders | SNOMED CT | Systematic Assessment |
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| Infection of gastrointestinal tract | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
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| Acid reflux | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
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| Stomach ache | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
|
| menstrual problem | Reproductive system and breast disorders | SNOMED CT | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| cramp | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| low back pain | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| Tendinitis | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| rupture of meniscus of knee | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| common cold | Infections and infestations | SNOMED CT | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | SNOMED CT | Systematic Assessment |
|
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |