Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).

Rochester Center for Behavioral Medicine26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Adult Attention-Deficit Hyperactivity Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Outcomes

Primary Outcomes

ADHD-RS Change From Baseline to Endpoint

The ADHD-RS is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared the mean change in ADHD-RS total score from baseline to endpoint of the study.

Time frame: 0 weeks, 8 weeks

Secondary Outcomes

The Clinical Global Impression (Severity)

The Clinical Global Impression- Severity (CGI-S) is a clinician-assessed likert scale used to determine the severity of a patient's presenting symptoms. The scale evaluates a subject's illness from 1 (normal, not at all ill) to 7 (extremely ill). The results reported below indicate the magnitude of change in terms of mean points on a scale for each study condition (IMP or Placebo).

Time frame: 0 weeks, 8 weeks

The Clinical Global Impression- Improvement (CGI-I)

The Clinical Global Impression-Improvement (CGI-I) is a clinician-assessed likert scale measuring change in presenting symptoms from previous visit. The CGI-I is a 7-item scale with with 1 indicating that the subject has very much improved and 7 indicating that the subject has become very much worse.

Time frame: 8 weeks