Social Phobia Clinical Trial
— SADOfficial title:
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
Verified date | May 2012 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)
Status | Completed |
Enrollment | 50 |
Est. completion date | November 2005 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion criteria: - Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria. - Must give a written informed consent. - If the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent. - Patients have a minimum score of 60 on the LSAS total score. Exclusion criteria: - Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24 weeks before week -2. - Patients with a history or complication of schizophrenia and bipolar disorder - Patients with a complication of body dysmorphic disorder. - Patients with evidence of substance abuse (alcohol or drugs). - substance dependence by DSM-IV-TR criteria within 24 weeks before week -2. - Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy. - Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2. - Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant. - Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide. - Patients with a history or complication of cancer or malignant tumor. - Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | GSK Investigational Site | Saitama | |
Japan | GSK Investigational Site | Tokyo | |
Spain | GSK Investigational Site | Unknown |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Japan, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0) | 52 Weeks | ||
Secondary | Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment. | 52 Weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
Completed |
NCT01570400 -
Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT
|
N/A | |
Recruiting |
NCT01388231 -
Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice
|
Phase 2/Phase 3 | |
Completed |
NCT00684541 -
Interpretation Modification Program for Social Phobia
|
N/A | |
Completed |
NCT00434759 -
Social Phobia Intervention Study of Mannheim
|
N/A | |
Completed |
NCT00380731 -
Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
|
N/A | |
Completed |
NCT03647605 -
Pilot Study: VR Mind and VR Mind+ Intervention
|
N/A | |
Not yet recruiting |
NCT03241277 -
Nonsurgical Periodontal Treatment in Patients With Social Phobia
|
N/A | |
Completed |
NCT02648737 -
Cognitive Behavioural Therapy for Anxiety Disorders in PD
|
N/A | |
Completed |
NCT02294409 -
Manualized Group Cognitive-behavioral Therapy for Social Anxiety in First Episode Psychosis
|
N/A | |
Terminated |
NCT01979263 -
Attention Bias Modification Treatment for Anxious Youth
|
N/A | |
Completed |
NCT01463137 -
Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
|
N/A | |
Completed |
NCT00774150 -
Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study
|
N/A | |
Completed |
NCT00326430 -
Residential Cognitive and Interpersonal Therapy for Social Phobia
|
Phase 2/Phase 3 | |
Completed |
NCT00000389 -
Treatment for Anxiety in Children
|
Phase 3 | |
Completed |
NCT00397722 -
Treatment Of Patients With Social Anxiety Disorder
|
Phase 2 | |
Completed |
NCT02678624 -
Project Collabri for Treatment of Anxiety
|
N/A | |
Completed |
NCT00564967 -
A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy
|
Phase 3 | |
Completed |
NCT00403962 -
A Combination Therapy In Patients With Social Anxiety Disorder
|
Phase 2 | |
Completed |
NCT00012584 -
Treatment of Youth With ADHD and Anxiety
|
N/A |