Last updated: 11/04/2018 10:15:01
Social Anxiety Disorder Study Of Paroxetine
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) A Double-blind, Placebo-controlled Study
Trial description: This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in the LSAS total overall score at Week 12
Timeframe: Baseline (Week 0) and Week 12
Secondary outcomes:
Percentage of participants responding with a Clinical Global Impression (CGI) Global Improvement Item score at Week 12
Timeframe: Week 12
Change from Baseline in LSAS total score at Weeks 2, 3, 4, 6, 8 and 10
Timeframe: Baseline (Week 0) up to Week 10
Change from Baseline in LSAS Fear/Anxiety subscale score at Weeks 2, 3, 4, 6, 8, 10 and 12
Timeframe: Baseline (Week 0) up to Week 12
Change from Baseline in LSAS Avoidance subscale score at Weeks 2, 3, 4, 6, 8, 10 and 12
Timeframe: Baseline (Week 0) up to Week 12
Change from Baseline in CGI severity of illness score at Weeks 2, 3, 4, 6, 8, 10 and 12
Timeframe: Baseline (Week 0) up to Week 12
Change from Baseline in Hamilton Rating Scale for Depression (HAM-D) total score at Week 12
Timeframe: Baseline (Week 0) and Week 12
Percentage of participants continuing treatment
Timeframe: Up to Week 12
Interventions:
Drug: Paroxetine 20 mg
Drug: Paroxetine 40 mg
Drug: Placebo
Enrollment:
399
Observational study model:
Not applicable
Primary completion date:
2006-01-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Social Phobia
Product
paroxetine
Collaborators
Not applicable
Study date(s)
December 2005 to November 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- 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. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- 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 24weeks before week -2.
- Patients with a history or complication of schizophrenia and bipolar disorder
Inclusion and exclusion criteria
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. But 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 24weeks 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-01-11
Actual study completion date
2006-01-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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