DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Rochester Center for Behavioral Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Attention-Deficit Hyperactivity Disorder

Intervention: Guanfacine Hydrocholride (Drug); Guanfacine Hydrocholride (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Rochester Center for Behavioral Medicine

Official(s) and/or principal investigator(s):
Joel L Young, MD, Principal Investigator, Affiliation: Rochester Center for Behavioral Medicine

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Safety and efficacy of GH as adjunctive medication to psychostimulants in adult ADHD

Secondary outcome: Assess safety and tolerability of GH.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Rochester Center for Behavioral Medicine, Rochester Hills, Michigan 48307, United States
Additional Information

Starting date: November 2012
Last updated: December 2, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017