Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effectiveness and tolerability of atomoxetine (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder characterized by a fear of interpersonal interactions).
Controlled studies show that approximately 50% of patients with generalized social anxiety disorder(GSAD)will respond to treatment with available pharmacotherapeutic agents such as SSRI's. This still leaves 50% that respond partially or not at all. Those who do respond, often experience adverse events (e.g., sexual dysfunction), which leads them to discontinue treatment. Thus, there is a strong rational for identifying alternatives to SSRI's that are effective with fewer side effects (or with a different side-effect profile, that features less sexual dysfunction)for the treatment of GSAD. Available data demonstrate that sustained-release venlafaxine, a dual reuptake inhibitor, is also effective for GSAD.(Stein et al., 2005). It is unclear from these studies whether serotonin reuptake is integral to efficacy for social anxiety disorder, or whether norepinephrine reuptake will convey similar efficacy. Atomoxetine (Strattera)an inhibitor of the presynaptic norepinephrine transporter, is an ideal candidate to address both these issues.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Atomoxetine |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atomoxetine | Drug | Flexible dose, up to 50 mg per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (Change Version, Also Known as Improvement Version) | This is a commonly used, clinician-rated measure of clinical improvement. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. For purposes of analysis, subjects rated as "(1) Very Much Improved" or "(2) Much Improved" were considered "responders". | 10 weeks (end of study) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Murray B Stein, M.D. | University of California, San Diego | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19910721 | Result | Ravindran LN, Kim DS, Letamendi AM, Stein MB. A randomized controlled trial of atomoxetine in generalized social anxiety disorder. J Clin Psychopharmacol. 2009 Dec;29(6):561-4. doi: 10.1097/JCP.0b013e3181bf6303. |
| Label | URL |
|---|---|
| UCSD Anxiety Disorders Research Program | View source |
Not provided
Not provided
Outpatient recruitment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Atomoxetine 40-100 mg per day |
| FG001 | Placebo | Placebo (matched capsules to atomoxetine) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Atomoxetine |
| BG001 | Placebo | Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Clinical Global Impression (Change Version, Also Known as Improvement Version) | This is a commonly used, clinician-rated measure of clinical improvement. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. For purposes of analysis, subjects rated as "(1) Very Much Improved" or "(2) Much Improved" were considered "responders". | Posted | Number | participants | 10 weeks (end of study) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Atomoxetine |
Not provided
Not provided
Small study, with possibility of Type II error. Nonetheless, response rates in both arms were very low, making it unlikely that the failure to see a response to atomoxetine was due to low power compared to placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murray B. Stein MD, MPH | University of California San Diego | 858-534-6400 | mstein@ucsd.edu |
| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | placebo (matching to atomoxetine) |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | Placebo | 0 | 13 | 0 | 13 |
Not provided
Not provided