Study Of 323U66 SR In Major Depressive Disorder

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder

Treatments: Drug: bupropion hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135512

AK1102364

Details and patient eligibility

About

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

Enrollment: 234 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)