Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65). (ADINT2012)

Rochester Center for Behavioral Medicine

Status and phase: Completed; Phase 4

Conditions: Adult Attention-Deficit Hyperactivity Disorder

Treatments: Other: Placebo; Drug: Guanfacine Hydrochloride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02141113

1129704 ADINT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Guanfacine Hydrochloride

Active Comparator group

Description:

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)

Treatment:

Drug: Guanfacine Hydrochloride

Sugar Pill

Placebo Comparator group

Description:

1. mg Placebo 2. mg Placebo 3. mg Placebo 4. mg Placebo 5. mg Placebo 6. mg Placebo

Treatment:

Other: Placebo