Adult Attention-Deficit Hyperactivity DisorderPhase 4ADINT2012NCT02141113
Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).
A Phase 4 study testing Guanfacine Hydrochloride in people with Adult Attention-Deficit Hyperactivity Disorder, run by Rochester Center for Behavioral Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult Attention-Deficit Hyperactivity Disorder
- What is being tested?
- Guanfacine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
About this study
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
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.
Read the 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.
- Being tested
- Guanfacine Hydrochloride, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanfacine HydrochlorideDrug
Also called Intuniv
- mg Guanfacine Hydrochloride (orally)
- mg Guanfacine Hydrochloride (orally)
- mg Guanfacine Hydrochloride (orally)
- mg Guanfacine Hydrochloride (orally)
- mg Guanfacine Hydrochloride (orally)
- mg Guanfacine Hydrochloride (orally)
PlaceboOther
Placebo of matching mg
| Study group | Role | What they receive |
|---|---|---|
| Guanfacine Hydrochloride | Active comparator | 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) Receives: Drug: Guanfacine Hydrochloride |
| Sugar Pill | Placebo comparator | 1. mg Placebo
2. mg Placebo
3. mg Placebo
4. mg Placebo
5. mg Placebo
6. mg Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 weeks, 8 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Attention-Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rochester Center for Behavioral Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Joel L Young, MD, Principal investigator, Rochester Center for Behavioral Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141113
- Sponsor's protocol ID
- 1129704 ADINT
- Acronym
- ADINT2012
- Status last verified
- Jul 2025
- First submitted
- 20 Nov 2013
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Butterfield ME, Saal J, Young B, Young JL. Supplementary guanfacine hydrochloride as a treatment of attention deficit hyperactivity disorder in adults: A double blind, placebo-controlled study. Psychiatry Res. 2016 Feb 28;236:136-141. doi: 10.1016/j.psychres.2015.12.017. Epub 2015 Dec 17.
PubMed 26730446
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02141113
- Acronym / sponsor ID
- ADINT2012 / 1129704 ADINT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rochester Center for Behavioral MedicineUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Nov 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guanfacine Hydrochloride | Active comparator | Drug: Guanfacine Hydrochloride1. 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) |
| Sugar Pill | Placebo comparator | Other: Placebo1. mg Placebo 2. mg Placebo 3. mg Placebo 4. mg Placebo 5. mg Placebo 6. mg Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guanfacine HydrochlorideAlso: Intuniv1. mg Guanfacine Hydrochloride (orally) 2. mg Guanfacine Hydrochloride (orally) 3. mg Guanfacine Hydrochloride (orally) 4. mg Guanfacine Hydrochloride (orally) 5. mg Guanfacine Hydrochloride (orally) 6. mg Guanfacine Hydrochloride (orally) | Drug | Guanfacine Hydrochloride |
| PlaceboPlacebo of matching mg | Other | Sugar Pill |
Primary outcome
ADHD-RS Change From Baseline to Endpoint
Time frame: 0 weeks, 8 weeks
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.
2 secondary outcomes
The Clinical Global Impression (Severity)
Time frame: 0 weeks, 8 weeks
The Clinical Global Impression- Improvement (CGI-I)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26730446Butterfield ME, Saal J, Young B, Young JL. Supplementary guanfacine hydrochloride as a treatment of attention deficit hyperactivity disorder in adults: A double blind, placebo-controlled study. Psychiatry Res. 2016 Feb 28;236:136-141. doi: 10.1016/j.psychres.2015.12.017. Epub 2015 Dec 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel L Young, MD principal investigator
Rochester Center for Behavioral Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guanfacine Hydrochloride in people with Adult Attention-Deficit Hyperactivity Disorder, run by Rochester Center for Behavioral Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD-RS Change From Baseline to Endpoint (time frame: 0 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02141113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.