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

Phase 4

Completed

• Conditions: Adult Attention-Deficit Hyperactivity Disorder
• Interventions: Drug: Guanfacine Hydrocholride

• Registration Number: NCT02141113
• Lead Sponsor: Rochester Center for Behavioral Medicine

Brief 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.

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-19
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Pill Guanfacine Hydrocholride	Guanfacine Hydrocholride	1. mg Guanfacine Hydrochloride (orally, QD) 2. mg Guanfacine Hydrochloride (orally, QD) 3. mg Guanfacine Hydrochloride (orally, QD) 4. mg Guanfacine Hydrochloride (orally, QD) 5. mg Guanfacine Hydrochloride (orally, QD) 6. mg Guanfacine Hydrochloride (orally, QD)
Guanfacine Hydrocholride	Guanfacine Hydrocholride	1. mg Guanfacine Hydrochloride (orally, QD) 2. mg Guanfacine Hydrochloride (orally, QD) 3. mg Guanfacine Hydrochloride (orally, QD) 4. mg Guanfacine Hydrochloride (orally, QD) 5. mg Guanfacine Hydrochloride (orally, QD) 6. mg Guanfacine Hydrochloride (orally, QD)

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of GH as adjunctive medication to psychostimulants in adult ADHD	8 weeks	Will be evaluated using three primary measures; 1: ADHD rating scale with adult prompts (ADHD-RS), 2:Clinical Global Impression-Improvement (CGI-I, and 3: Clinical Global Impression-Severity (CGI-S).

Secondary Outcome Measures

Name	Time	Method
Assess safety and tolerability of GH.	Pre-treatment, during treatment, end of study (8 weeks)	Aside from exploring general safety and tolerability of GH, the study will also investigate the safety and tolerability of 5mg and 6mg doses of GH and the safety and tolerability of down titration of GH at the end of the study. Safety of GH will be assessed throughout the course of the study through the collection of a series of vitals, including: blood pressure, weight, pulse rate, and physical examination.; Medication tolerability will be assessed by surveying levels of fatigue (Fatigue Symptoms Inventory), sleep quality (Pittsburgh Sleep Quality Index (PSQI)), anxiety (Hamilton Anxiety Rating Scale (HAM-A)), mood (Hamilton Depression Rating Scale (HAM-D)), and sexual functioning (Arizona Sexual Experience Scale (ASEX)) throughout the course of the study.

Trial Locations

Locations (1)

Rochester Center for Behavioral Medicine; 🇺🇸 Rochester Hills, Michigan, United States