[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site

Study’s contact

Call center

312-413-9462

Email address

amaass@psych.uic.edu

Condition

Attention Deficit Hyperactivity Disorder

Treatment type

Interventional

Investigational product

Behavior Parent Training

Phase

Phase 4

Sponsor

Seattle Children's Hospital

ClinicalTrials.gov identifier

NCT01816074

Study number

20120189

Date first posted

March 5, 2013

Date last update

March 7, 2017

Understanding clinical trials

Get answers to your questions about clinical trials.

About the study

We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder (ADHD) will have a beneficial effect that extends to the child. We believe that multi-component interventions combining maternal stimulant medication, Lisdexamfetamine (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may benefit most from multi-modal treatment

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Sign informed consent
  2. Be between 21-50 years old (inclusive) at the screening visit and English-speaking
  3. At screening (after washout, if required) meet full Diagnostic and Statistical Manual (DSM-IV) criteria for ADHD, any subtype
  4. Have current CGI-S-ADHD rating > 4 and < 8
  5. Have findings on physical exam (PE), laboratory studies, vital signs, and electrocardiogram (ECG) judged to be normal for age with no contraindications for methylphenidate (MPH) treatment
  6. Have pulse and blood pressure (BP) within 95% of age and gender mean
  7. Commit to the entire visit schedule for the study
  8. Be able to complete all study assessments
  9. Women of childbearing potential (not surgically sterile or post-menopausal) must agree to use a medically-accepted contraception method consistently
  10. Mothers with comorbid mood/anxiety disorders which are effectively treated with Selective Serotonin Reuptake Inhibitors (SSRIs) will be eligible for participation, provided this medication has not changed within 30 days, is well tolerated, and that current mood symptoms are not severe or associated with active suicidal ideation. Also, the prescribing physician must approve of their participation in the study. Mothers
Exclusion criteria
  1. History of allergic reactions or severe negative response to study medications
  2. History of alcohol/substance abuse in the past 3 months or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance
  3. History of or current bipolar illness, schizophrenia, psychoses, or significant suicidal risk
  4. History of chronic or acute medical disorder for which stimulant therapy would be contraindicated (e.g., glaucoma, hypertension) Child

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site