Last updated: 11/04/2018 05:46:12
Study Of Generalized Anxiety Disorder
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder
Trial description: This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder patients
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in the Hamilton Anxiety Scale (HAM-A) total score (at Week 8, last observation carried forward [LOCF])
Timeframe: 8 Weeks
Secondary outcomes:
Mean change from baseline in the HAM-A score (at Weeks 1, 2, 4 and 6); in the Severity of Illness (CGI SI) score; in the SDS and MADRS total scoreProportion of responders based on the Clinical Global Impression Global Improvement (CGI GI) score
Timeframe: 8 Weeks
Interventions:
Drug: Paroxetine
Drug: Placebo
Enrollment:
Not applicable
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Anxiety Disorder
Product
paroxetine
Collaborators
GSK
Study date(s)
May 2003 to October 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Diagnosis of Generalized Anxiety Disorder (GAD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) 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.
- Have the following conditions currently or diagnosed in the past 24 weeks:
- Major Depressive Episode, Panic Disorder Without Agoraphobia, Panic Disorder With Agoraphobia, Social phobia/social anxiety disorder (SAD), Agoraphobia Without History of Panic Disorder, Posttraumatic Stress Disorder, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Dysthymic disorder
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of Generalized Anxiety Disorder (GAD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) 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.
Exclusion criteria:
- Have the following conditions currently or diagnosed in the past 24 weeks: Major Depressive Episode, Panic Disorder Without Agoraphobia, Panic Disorder With Agoraphobia, Social phobia/social anxiety disorder (SAD), Agoraphobia Without History of Panic Disorder, Posttraumatic Stress Disorder, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Dysthymic disorder
- Current or history of schizophrenia, bipolar disorder or cyclothymic disorder.
- Psychotherapy or cognitive behavioral therapy other than supportive psychotherapy.
- Current or history of substance abuse (alcohol or drugs) or substance in past 24 weeks.
- Taken St. John’s Wort in past 4 weeks.
- Had electroconvulsive therapy (ECT) in past 12 weeks.
- Had psychotherapy or cognitive behavioral therapy other than supportive psychotherapy within 24 weeks.
- Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancy by 30 days after the completion of final dose.
- Pose a suicidal threat or have attempted suicide in past 24 weeks.
- History of convulsive disorder (epilepsy, etc.).
- Significant unstable medical illness.
- Current or history of glaucoma.
- History or complication of cancer or malignant tumor.
- History of hypersensitivity to paroxetine.
Trial location(s)
No location data available.
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
Not applicable
Actual study completion date
2005-25-10
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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