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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guanfacine Hydrochloride | Active Comparator |
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| Sugar Pill | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanfacine Hydrochloride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Symptoms Inventory (FSI) Change From Baseline to Endpoint | The FSI is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life. Severity is measured on separate 11-point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue since last visit, as well as current fatigue. The minimum score would be 0, maximum score would be 140. Scores below reflect mean improvement in FSI score from baseline (visit 0) to endpoint (visit 8). The FSI was used to measure safety and tolerability of study drug. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel L Young, MD | Rochester Center for Behavioral Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26730446 | Derived | 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. |
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All participants were on a stable dose (as determined by the investigator) of a stimulant medication.
Study site began recruiting for the trial in November 2012 and the last subject completed the final visit on 3/7/14. Recruitment was done from within the Rochester Center for Behavioral Medicine (a private mental health practice), as well as community outreach.
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| ID | Title | Description |
|---|---|---|
| FG000 | Guanfacine Hydrocholride |
Guanfacine Hydrocholride: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally) |
| FG001 | Sugar Pill Guanfacine Hydrocholride |
Guanfacine Hydrocholride: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Guanfacine Hydrocholride |
Guanfacine Hydrocholride: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 weeks, 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Guanfacine Hydrochloride 1, 2, 3, 4, 5, or 6 mg |
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Relatively small sample size and herterogenous sample (male paticipants = 14 and female participants = 12).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel L. Young, MD | Rochester Center for Behavioral Medicine | 2486088800 | jyoung@rcbm.net |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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|
| Placebo | Other | Placebo of matching mg |
|
| 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. | 8 weeks |
| 0 weeks, 8 weeks |
| Hamilton Anxiety Inventory Change From Baseline to Endpoint | The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 8 between guanfacine hyrdochloride and placebo-treated patients to assess safety and tolerability of study drug. | 0 weeks, 8 weeks |
| Arizona Sexual Experiences Scale (ASEX) Change From Baseline to Endpoint | The Arizona Sexual Experiences Scale (ASEX) is both a self-administered or clinician-administered questionnaire. It is a user-friendly 5-item rating scale. The ASEX utilizes short, easy to understand, and less intrusive questions that explores the follwoing aspects of sexuality:
4. ability to reach orgasm 5. satisfaction from orgasm Scores can range from a minimum of 6 (indicating minimal problems with sexual functioning) to 36 (indicating maximum problems with sexual functioning). Mean change from baseline (visit 0) to endpoint (visit 8) are presented below. The ASEX was used to assess safety and tolerability of drug from baseline to endpoint | 0 weeks, 8 weeks |
| Hamilton Depression Rating Scale (HAM-D) Change From Baseline to Endpoint | The HAM-D is a clinician administered multiple item scale used to provide an indication of depression symptom severity. It is designed for adults. Each item on the questionnaire is scored on a 3 or 5 point scale. The HAM-D is comprised of 21 items, however, the total score is based on the sum of the scores from the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Thus the possible total score range is 0 (minimum) to 40 (maximum) with a higher score indicating greater severity of depression. Accordingly, a low HAM-D score would indicate a better outcome. Mean change scores from baseline (visit 0) to endpoint (visit 8) are presented below. | 0 weeks, 8 weeks |
| The Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to Endpoint | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The individual self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. Total score range is from 0 to 21. The mean improvement from baseline (visit 0) to endpoint (visit 8) are presented below. PSQI was used to assess safety and tolerability of study drug. | 0 weeks, 8 weeks |
| BG001 | Sugar Pill Guanfacine Hydrocholride |
Guanfacine Hydrocholride: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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). | Participants | Posted | Mean | 95% Confidence Interval | units on a scale | 0 weeks, 8 weeks |
|
|
|
|
| Secondary | 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. | Participants | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
|
| Other Pre-specified | Fatigue Symptoms Inventory (FSI) Change From Baseline to Endpoint | The FSI is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life. Severity is measured on separate 11-point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue since last visit, as well as current fatigue. The minimum score would be 0, maximum score would be 140. Scores below reflect mean improvement in FSI score from baseline (visit 0) to endpoint (visit 8). The FSI was used to measure safety and tolerability of study drug. | Participants | Posted | Mean | 95% Confidence Interval | units on a scale | 0 weeks, 8 weeks |
|
|
|
|
| Other Pre-specified | Hamilton Anxiety Inventory Change From Baseline to Endpoint | The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 8 between guanfacine hyrdochloride and placebo-treated patients to assess safety and tolerability of study drug. | Participants | Posted | Mean | 95% Confidence Interval | units on a scale | 0 weeks, 8 weeks |
|
|
|
|
| Other Pre-specified | Arizona Sexual Experiences Scale (ASEX) Change From Baseline to Endpoint | The Arizona Sexual Experiences Scale (ASEX) is both a self-administered or clinician-administered questionnaire. It is a user-friendly 5-item rating scale. The ASEX utilizes short, easy to understand, and less intrusive questions that explores the follwoing aspects of sexuality:
4. ability to reach orgasm 5. satisfaction from orgasm Scores can range from a minimum of 6 (indicating minimal problems with sexual functioning) to 36 (indicating maximum problems with sexual functioning). Mean change from baseline (visit 0) to endpoint (visit 8) are presented below. The ASEX was used to assess safety and tolerability of drug from baseline to endpoint | All participants were included in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 0 weeks, 8 weeks |
|
|
|
|
| Other Pre-specified | Hamilton Depression Rating Scale (HAM-D) Change From Baseline to Endpoint | The HAM-D is a clinician administered multiple item scale used to provide an indication of depression symptom severity. It is designed for adults. Each item on the questionnaire is scored on a 3 or 5 point scale. The HAM-D is comprised of 21 items, however, the total score is based on the sum of the scores from the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Thus the possible total score range is 0 (minimum) to 40 (maximum) with a higher score indicating greater severity of depression. Accordingly, a low HAM-D score would indicate a better outcome. Mean change scores from baseline (visit 0) to endpoint (visit 8) are presented below. | Posted | Mean | 95% Confidence Interval | units on a scale | 0 weeks, 8 weeks |
|
|
|
| Other Pre-specified | The Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to Endpoint | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The individual self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. Total score range is from 0 to 21. The mean improvement from baseline (visit 0) to endpoint (visit 8) are presented below. PSQI was used to assess safety and tolerability of study drug. | Posted | Mean | 95% Confidence Interval | units on a scale | 0 weeks, 8 weeks |
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| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Control Group | Placebo 1, 2, 3, 4, 5, or 6 mg | 0 | 13 | 0 | 13 |
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| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |