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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Adult Attention-Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Guanfacine Hydrocholride
* Drug: Guanfacine Hydrocholride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guanfacine Hydrocholride<br>mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) | Drug: Guanfacine Hydrocholride<br>* mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally)<br>* Other names: Intuniv;|
| Placebo Comparator: Sugar Pill Guanfacine Hydrocholride<br>mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) mg Guanfacine Hydrochloride (orally, QD) | Drug: Guanfacine Hydrocholride<br>* mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally)<br>* Other names: Intuniv;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of GH as adjunctive medication to psychostimulants in adult ADHD | 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). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of GH. | 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. | Pre-treatment, during treatment, end of study (8 weeks) |