Study Of 323U66 SR In Major Depressive Disorder

An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients With Depression

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

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.