Study Of 323U66 SR In Major Depressive Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-01

Study Completion Date

2007-05-28

Brief Summary

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This study was designed to evaluate the efficacy and safety in major depressive disorder patients.

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Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bupropion hydrochloride

Study drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
* 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.
* Must have rating scores as outlined.

Exclusion Criteria

* Current or past history of seizure disorder or brain injury.
* Current or past history of anorexia or bulimia nervosa.
* History of manic episode.
* Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.
* Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.
* Pregnant, possibly pregnant or lactating.
* Must not be suicidal.
* Blood pressure of SBP\>160mmHg, DBP\>100mmHg.
* History or complication of cancer or malignant tumour.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No