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

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.

Time frame: 0 weeks, 8 weeks

Population: All participants were included in the analysis.

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.

Time frame: 8 weeks

Population: 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).

Time frame: 0 weeks, 8 weeks

Population: Participants

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

Time frame: 0 weeks, 8 weeks

Population: All participants were included in the analysis.

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.

Time frame: 0 weeks, 8 weeks

Population: 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.

Time frame: 0 weeks, 8 weeks

Population: Participants

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.

Time frame: 0 weeks, 8 weeks

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.

Time frame: 0 weeks, 8 weeks