NCT00773916

Brief Summary

The purpose of this study is to investigate the association of adverse environmental factors, parental psychopathology, family functioning and genetic factors and the response to methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

Enrollment Period

2.3 years

First QC Date

October 15, 2008

Last Update Submit

August 14, 2009

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit DisorderAttention Deficit Disorders with HyperactivityHyperkinetic SyndromeFamily FunctionAdverse FactorsParental Psychopathology

Outcome Measures

Primary Outcomes (2)

  • SNAP -IV scores

    1, 2, 3 and 6 months of treatment

  • CGI scores

    1, 2, 3 and 6 months of treatment

Secondary Outcomes (1)

  • Scores in CGAS

    1, 2, 3 and 6 months of treatment

Interventions

MethylphenidateDRUG

Dose increments according to clinical evaluation, starting with 0,3 mg/kg of weight/day

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ADHD
  • Age: 5 - 18
  • Primary Indication of Methylphenidate

You may not qualify if:

  • IQ \< 70
  • Clinical conditions that preclude use of methylphenidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ADHD Outpatient Program - Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luis A Rohde, MD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

March 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2009

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations

BR(1)