Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | November 2012 |
| End Date: | November 2014 |
Double-Blind, Randomized, Placebo-Controlled, Single- Center, Dose Optimization Study Evaluating Efficacy and Safety of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults Aged 18-65 Years With a Diagnosis of ADHD
This is considered an investigator-initiated clinical research trial, which means that your
study doctor is researching a particular medication (in this case a medication that is
currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication
is guanfacine hydrochloride.
The hypothesis is that this medication could be used in adults with Attention
Deficit/Hyperactivity Disorder who have not received satisfactory results with their current
stimulant ADHD medication. The study drug is investigational for use in adults.
Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA)
for use in adults.
study doctor is researching a particular medication (in this case a medication that is
currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication
is guanfacine hydrochloride.
The hypothesis is that this medication could be used in adults with Attention
Deficit/Hyperactivity Disorder who have not received satisfactory results with their current
stimulant ADHD medication. The study drug is investigational for use in adults.
Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA)
for use in adults.
The purpose of this study is to determine whether guanfacine hydrochloride used as an adjunct
therapy (to subjects' current stimulant medication) would bring about a statistically
significant improvement in AD/HD symptoms.
therapy (to subjects' current stimulant medication) would bring about a statistically
significant improvement in AD/HD symptoms.
Inclusion:
- Male and females (non pregnant) ages 18-65
- Current diagnosis of ADHD and have met the DSM-IV-TR criteria for ADHD
- Currently taking an adequate dose stimulant to treat their ADHD (with a sub-optimal
response). A suboptimal response is determined by a baseline score of 28 or greater on
the ADHD-RS or a CGI score of 4 or greater.
- Subjects must be of normal intelligence
- English speaking
- Able to swallow pills.
Exclusion:
- Non pregnant or lactating females
- Severe Axis I and Axis II disorders
- Suicidal
- Tourette's
- Heart disease or any other serious chronic or acute unstable medical
conditions/illnesses that would compromise participation or likely lead to
hospitalization during the duration of the study.
- A known history or presence of cardiovascular, hepatic, renal, respiratory, or
hematologic abnormalities, narrow angle glaucoma, or any other unstable medical or
psychiatric conditions (as judged by the primary investigator)
- A current or recent history (within the past 6 months) of suspected substance abuse
and/or drug dependence as defined by DSM-IV-TR criteria
- Healthy weight (not under or over as judged by investigator)
- No immediate family member of the investigator or research staff No involvement in a
research study in the last 30 days.
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