Last updated: 11/04/2018 10:12:24
A Local Register Study For Major Depression Of Paroxetine Controlled Release
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicentre, Double-blind, Active Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Controlled Release Paroxetine in the Treatment of Major Depression
Trial description: The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to Paroxetine Immediate Release, as well as the drug tolerability profile when treated on patients with Major Depression.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Paroxetine CR
Drug: Paroxetine IR
Enrollment:
362
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder, Major
Product
paroxetine
Collaborators
Not applicable
Study date(s)
December 2006 to August 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale>18).
- patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other Axis I disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1C antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than MAO inhibitors within 7 days of baseline and MAO inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale>18).
Exclusion criteria:
- patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other Axis I disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1C antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than MAO inhibitors within 7 days of baseline and MAO inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis.
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
Not applicable
Actual study completion date
2007-14-08
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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