A Local Register Study For Major Depression Of Paroxetine Controlled Release

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Disorder, Major Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Paroxetine CR

Intervention Type DRUG

Paroxetine IR

Intervention Type DRUG

Other Intervention Names

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Paroxetine CR

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No