Anxiety Disorder
Conditions
Keywords
Double Blind, Placebo controlled, Safety and Efficacy, Generalized Anxiety Disorder
Brief summary
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
Detailed description
Protocol 04-001-01 The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD). The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication. Recruiting: Participants are currently being recruited and enrolled.
Interventions
DRUGexperimental anti-anxiety drug
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.
Exclusion criteria
* No other primary psychiatric diagnosis besides GAD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HAM-A Total Score | Baseline to week 8 | Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OROS Alprazolam | 165 |
| IR Alprazolam | 169 |
| Placebo | 149 |
| Total | 483 |
Baseline characteristics
| Characteristic | IR Alprazolam | Placebo | OROS Alprazolam | Total |
|---|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 12.02 | 38.5 years STANDARD_DEVIATION 11.13 | 39.1 years STANDARD_DEVIATION 12 | 38.8 years STANDARD_DEVIATION 11.72 |
| Age, Customized 40 - < 65 years | 78 participants | 58 participants | 76 participants | 212 participants |
| Age, Customized < 40 years | 90 participants | 91 participants | 87 participants | 268 participants |
| Age, Customized >=65 years | 1 participants | 0 participants | 2 participants | 3 participants |
| Region of Enrollment United States | 169 participants | 149 participants | 165 participants | 483 participants |
| Sex: Female, Male Female | 113 Participants | 103 Participants | 95 Participants | 311 Participants |
| Sex: Female, Male Male | 56 Participants | 46 Participants | 70 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 140 / 171 | 141 / 176 | 118 / 160 |
| serious Total, serious adverse events | 6 / 171 | 1 / 176 | 0 / 160 |
Outcome results
Primary
Change in HAM-A Total Score
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
Time frame: Baseline to week 8
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OROS Alprazolam | Change in HAM-A Total Score | -12.9 Units on a Scale |
| IR Alprazolam | Change in HAM-A Total Score | -15.7 Units on a Scale |
| Placebo | Change in HAM-A Total Score | -12.5 Units on a Scale |
p-value: 0.65495% CI: [-2.2, 1.4]ANCOVA
p-value: 0.000595% CI: [-5, -1.4]ANCOVA
p-value: 0.001595% CI: [1.1, 4.5]ANCOVA