N/A
N=12
Treatment of Executive Dysfunction in Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00286949 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Clinical Global Impression of Change-Clinician Rated Score (CGIC-C) — 3; 6; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Atomoxetine (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression of Change-Clinician Rated Score (CGIC-C) |
3; 6; 1; 2; 0; 0 | — |
| PRIMARY Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale |
60; 52 | — |
| PRIMARY Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore |
67; 58 | — |
Summary
Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance levels of brain chemicals that may be affected in people with executive dysfunction, (difficulties with organization, task completion, and priority setting). Thus, atomoxetine has the potential to improve executive dysfunction in people with Parkinson's disease (PD).
The goal of this study is to provide preliminary data on the effectiveness and tolerability of atomoxetine for the treatment of executive dysfunction in patients with PD.
Eligibility Criteria
Inclusion Criteria
- Men and women with idiopathic Parkinson's Disease, as defined by United Kingdom (UK) Brain Bank Criteria.
- Adults, ages 21 to 65 years old.
- Clinically significant executive dysfunction, as defined by the reported presence of problems with disorganization, distractibility, task completion, planning or problem solving that represents a decline from premorbid (pre-PD) status and is confirmed by the patient's informant.
- Mini-Mental State Exam (MMSE) score > 26.
- Absence of Dementia due to Parkinson's Disease, as defined by Diagnostic and Statistical Manual-IVth edition-Text revision (DSM-IV-TR).
- Clinical Dementia Rating (CDR) Scale score 10.
- For women, current pregnancy or nursing.
- Current use of potent CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, quinidine.
- Current use of stimulant or wakefulness therapy, e.g., methylphenidate or modafinil.
- Current hepatic dysfunction, defined as values of two times or greater than the upper limit of normal on the aspartate aminotransferase (AST) or alanine aminotransferase (ALT) hepatic enzymes or any disorder affecting the liver that in the opinion of the enrolling investigator would interfere with hepatic metabolism of the medication or interfere with the participant's ability to complete the study.
- Current use of monoamine oxidase inhibitors that are typically used for treatment of depression (isocarboxazid, phenelzine, and tranylcypromine).
Data sourced from ClinicalTrials.gov (NCT00286949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.