Overview

Study Of 323U66 SR In Major Depressive Disorder

Status:
Completed
Trial end date:
2007-05-28
Target enrollment:
0
Participant gender:
All
Summary
This study was designed to evaluate the efficacy and safety in major depressive disorder patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Bupropion
Criteria
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.