Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Copenhagen University Hospital, Denmark | OTHER |
Not provided
Not provided
Not provided
This is a prospective observational study of a cohort of children diagnosed with Attention Deficit Hyperactive Disorder (ADHD) and followed with weekly assessments during the first 12 weeks of Methylphenidate (MPH) treatment, and after three years.
The overall aim is to gain knowledge in order to develop guidelines for more individualized treatments with (MPH), obtain a better drug response, and reduce the risk of adverse reactions, in order to improve adherence and long-term outcome.
The study has three aims:
The specific aims are to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHD patients | Treatment of young ADHD patients with methylphenidate following The Danish guidelines, which are similar to The NICE guidelines: use of an initial low oral dose of MPH and an up-titration period of at least 4 weeks, until no further effect is measured on a standard ADHD rating scale, or the appearance of intolerable ARs, or a maximum dose of 2.1 mg/kg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | Treatment with methylphenidate through dose escalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator rated ADHD-RS score | Psychometric instrument: 18 item clinician rated; Inattention subscale: 9 items, [range 0-27]. Hyperactivity-Impulsivity subscale: 9 items [range 0-27], evaluated on a four-point Likert scale from 0 (none = never or rarely) to 3 (severe = very often). Higher score, worse outcome. Normalisation: T-score<60, Borderline normalisation: T-score 60-70. | Week 0 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Severity scale (CGI-S) | Psychometric instrument: The clinician-rated CGI-S is a seven-point Likert scale, rated 1 (normal, not ill at all) to 7 (among the most extremely ill patients)A beneficial symptom reduction was defined by a CGI-S score of 1 or 2 (normal, not ill at all or borderline ill). | Week 0 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Weiss Functional Impairment Rating Scale - Parent version (WFIRS-P). | Psychometric instrument: WFIRS-P is a parent-rated questionnaire, with 50 questions about a child's daily and social functioning in six different domains of a child's life: family (10 items), learning and school (10 items), activities of daily living (10 items), self-concept (3 items), social activities (7 items), and risky activities (10 items). It is evaluated on a four-point Likert scale from 0 (never or not at all) to 3 (very often or very much). Single item scores = 2-3 signal impairment (> 2 SD). Higher score, worse outcome. |
Inclusion Criteria:
Exclusion Criteria:
Specific additional exclusion criteria for genetic analyses:
Not provided
Not provided
207 MPH naïve boys and girls aged 7-12 years with a recent ICD-10 diagnosis of hyperkinetic disorder (F90.0-90.9) or attention deficit disorder without hyperactivity (F98.8) and clinical indication for treatment with IR-MPH.
Patients referred to the Child and Adolescent Mental Health Centre, Mental Health Services (Capital Region of Denmark) in the period from 1st of May 2012 to 1st August 2014, and who were suspected of having ADHD were consecutively screened for study eligibility.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pia Jeppesen, PhD, MD | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | Principal Investigator |
| Tine B Houmann, MD | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36795232 | Derived | Houmann TB, Kaalund-Brok K, Clemmensen L, Petersen MA, Plessen KJ, Bilenberg N, Verhulst F, Jeppesen P; INDICES. Early treatment response as predictor of long-term outcome in a clinical cohort of children with ADHD. Eur Child Adolesc Psychiatry. 2024 Feb;33(2):357-367. doi: 10.1007/s00787-023-02158-z. Epub 2023 Feb 16. | |
| 34673771 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2012 | Apr 24, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
DNA from saliva collected in the Oragene OG-250 DNA kit (DNA Genotek Inc., ON, Canada).
| Clinical Global Impression Improvement (CGI-I) |
Psychometric instrument, clinician-rated CGI-I seven-point Likert scale rated from 1 (very much improved) to 7 (very much worse). A beneficial symptom reduction was defined by a CGI-I score of 1 or 2 (very |
| Week 4-8-12 |
| Test of Variables of Attention (TOVA) | Computerized, continuous performance test, number of commission errors (response to non-target), number of omission errors (non-response to target), the response time in microseconds, and the variability of response time in correct responses to target were measured over the 21.6-minute-long test used as total raw scores. | Week 0 and 12 |
| Parent rated ADHD-RS | Psychometric instrument: Inattention subscale: 9 items, [range 0-27]. Hyperactivity-Impulsivity subscale: 9 items [range 0-27]. Conduct problems subscale: 8 items, [range 0-24]. Higher score, worse outcome. | Week 0-4-8-12, year 3 |
| Teacher rated ADHD-RS | Psychometric instrument: Inattention subscale: 9 items, [range 0-27]. Hyperactivity-Impulsivity subscale: 9 items [range 0-27]. Conduct problems subscale: 8 items, [range 0-24]. Higher score, worse outcome. | Week 0-4-8-12 |
| Week 0 and 12, year 3 |
| Barkley's Stimulant Side Effect Rating Scale (BSSERS-C) | Psychometric instrument: 17 effect items rated by the clinician, based on information from patients, parents, and clinical observations: insomnia, nightmares, staring, talks less, disinterested in others, reduced appetite, irritable, stomachaches, headaches, drowsiness, sadness, prone to crying, anxious, nail biting, euphoria, dizziness, and tics/nervous movements. BSSERS-C is a 10-point Likert scale rated from 0 (problem absent) to 9 (problem evokes serious impairment). Severities of ARs were calculated as the sum of problem scores on the 17-item BSSERS-C. Significant changes in single items were also explored (e.g., reduced appetite; 1 item, range 0-9). | Week 0 to 12 |
| Child Behaviour Check List (CBCL) | Psychometric instrument: Parent rated. Externalizing score: 35 items [range 0-70]. Internalizing score: 32 items [range 0-64]. Total problem score: 118 [range 0-236]. | Week 0 |
| Teacher Report Form (TRF) | Psychometric instrument: Teacher rated. Externalizing score, 34 items [range 0-68]. Internalizing score: 34 items [range 0-68]. Total problem score: 118 [range 0-236]. | Week 0 |
| MPH dose required for "Borderline normalisation" on ADHD-RS | The IR-MPH doses were individually titrated, based on the weekly evaluations of symptom reductions and ARs (and the body weight of a child), which were carried out by the clinical investigator. The dose of IR-MPH (mg/kg/day) at the end of the study was registered. Dose required for T-score of 60-70 on ADHD-DSM-IV-RS. | Week 0 to 12 |
| MPH dose required for normalisation on ADHD-RS | The IR-MPH doses were individually titrated, based on the weekly evaluations of symptom reductions and ARs (and the body weight of a child), which were carried out by the clinical investigator. The dose of IR-MPH (mg/kg/day) at the end of the study was registered. Dose required for T-score < 60 on ADHD-DSM-IV-RS. | Week 0 to 12 |
| Genetic analyses | The genetic analyses of CES1 were carried out using PCR and sequencing. | Week 0 |
| Body weight | Body weight in kilograms | Week 0-4-8-12 |
| Height | Height in centimeters | Week 0-4-8-12 |
| Heart rate | Heart rate, bp/m | Week 0-4-8-12 |
| Blood pressure | Both diastolic blood pressure, mmHg, and Systolic blood pressure, mmHg, measured after 10 minutes of rest with a sphygmomanometer (nonelectrical) three times and the average of the last two measures is used | Week 0-4-8-12 |
| Reduced appetite: single item, [range 0-9]. | Single item of psychometric instrument Barkley's Stimulant Side Effect Rating Scale (BSSERS-C), [range 0-9]. Higher value, worse outcome. | Week 0-4-8-12 |
| Kaalund-Brok K, Houmann TB, Hebsgaard MB, Lauritsen MG, Lundstrom LH, Gronning H, Darling L, Reinert-Petersen S, Petersen MA, Jepsen JRM, Pagsberg AK, Plessen KJ, Rasmussen HB, Jeppesen P; INDICES. Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naive children with ADHD. PLoS One. 2021 Oct 21;16(10):e0253727. doi: 10.1371/journal.pone.0253727. eCollection 2021. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |