Last updated: 02/14/2020 20:50:09
Long-term Study Of Paroxetine in Women and MenSAD
Clinicaltrials.gov ID
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 Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
Trial description: This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
Timeframe: 52 Weeks
Secondary outcomes:
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.
Timeframe: 52 Weeks
Interventions:
Drug: BRL29060A
Drug: paroxetine hydrochloride hydrate
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2006-14-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Social Phobia
Product
paroxetine
Collaborators
Not applicable
Study date(s)
October 2005 to December 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.
- 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
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.
- 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.
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2006-14-12
Actual study completion date
2006-14-12
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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