Trial Outcomes & Findings for Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65). (NCT NCT02141113)
NCT ID: NCT02141113
Last Updated: 2025-08-12
Results Overview
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.
COMPLETED
PHASE4
26 participants
0 weeks, 8 weeks
2025-08-12
Participant Flow
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.
All participants were on a stable dose (as determined by the investigator) of a stimulant medication.
Participant milestones
| Measure |
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: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally)
|
Sugar Pill 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: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).
Baseline characteristics by cohort
| Measure |
Guanfacine Hydrocholride
n=13 Participants
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: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally)
|
Sugar Pill Guanfacine Hydrocholride
n=13 Participants
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: 1mg Guanfacine Hydrochloride (orally) 2mg Guanfacine Hydrochloride (orally) 3mg Guanfacine Hydrochloride (orally) 4mg Guanfacine Hydrochloride (orally) 5mg Guanfacine Hydrochloride (orally) 6mg Guanfacine Hydrochloride (orally)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 weeks, 8 weeksPopulation: All participants were included in the analysis.
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.
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
ADHD-RS Change From Baseline to Endpoint
|
11.85 units on a scale
Standard Deviation 7.63
|
10.92 units on a scale
Standard Deviation 8.90
|
SECONDARY outcome
Timeframe: 0 weeks, 8 weeksPopulation: Participants
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).
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
The Clinical Global Impression (Severity)
|
.85 units on a scale
Interval 0.36 to 1.33
|
1.0 units on a scale
Interval 0.57 to 1.49
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants
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.
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
The Clinical Global Impression- Improvement (CGI-I)
|
2.77 units on a scale
Standard Deviation 1.01
|
2.92 units on a scale
Standard Deviation 1.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 weeks, 8 weeksPopulation: Participants
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.
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
Fatigue Symptoms Inventory (FSI) Change From Baseline to Endpoint
|
0.69 units on a scale
Interval -12.92 to 14.3
|
5.77 units on a scale
Interval -9.1 to 20.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 weeks, 8 weeksPopulation: Participants
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.
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
Hamilton Anxiety Inventory Change From Baseline to Endpoint
|
3.62 units on a scale
Interval 0.21 to 7.02
|
4.46 units on a scale
Interval 1.49 to 7.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 weeks, 8 weeksPopulation: All participants were included in the analysis.
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: 1. sex drive 2. arousal 3a. penile erection 3b. vaginal lubrication 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
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
Arizona Sexual Experiences Scale (ASEX) Change From Baseline to Endpoint
|
-.77 units on a scale
Interval -2.21 to 0.67
|
1.31 units on a scale
Interval -1.91 to 4.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D) Change From Baseline to Endpoint
|
3.31 units on a scale
Interval 0.14 to 6.48
|
4.23 units on a scale
Interval 1.93 to 6.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Treatment
n=13 Participants
Guanfacine hydrochloride 1, 2, 3, 4, 5 or 6 mg
|
Control Group
n=13 Participants
Matching placebo
|
|---|---|---|
|
The Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to Endpoint
|
2.69 units on a scale
Interval -1.24 to 6.63
|
2.08 units on a scale
Interval -0.01 to 4.16
|
Adverse Events
Treatment Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joel L. Young, MD
Rochester Center for Behavioral Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place