Study Of 323U66 SR In Major Depressive Disorder

NCTId: NCT00135512

Official Title

Clinical Evaluation of 323U66 SR in Patients With Depression - Open-Label Study -


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


Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years 64 Years False

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.

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

bupropion hydrochloride
bupropion hydrochloride

Study Outcomes

Primary Outcome(s)

Timeframe: 8 Weeks
Measure: Change from baseline in the MADRS(Montgomery-Asberg Depression Rating Scale) total score.

Secondary Outcome(s)

Measure: - Change from baseline in the HAM-D total score - Percentage of subjects who are CGI Global Improvement responders - Change from baseline in the SDS total score and the MEI-SF total score
Timeframe: 8 Weeks

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

GSK Investigational Site
Kumamoto, 861-8002 Japan

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Major Depressive Disorder (MDD)

Other Related Condition Keywords

  1. Depressive Disorder
  2. Depression
  3. Depressive Disorder, Major

Related Intervention Keywords

Related Major Depressive Disorder (MDD) Research

  1. A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder
  2. A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder
  3. A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
  4. A Study of Flexible or Fixed Dose LLY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment
  5. Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD)
  6. An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder
  7. An Investigation of Early Life Stress and Depression
  8. Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
  9. Cardiovascular Effects of Agomelatine and Escitalopram in Patients With Major Depressive Disorder
  10. Childhood Adversity, Genetic Polymorphisms and Stress in First Onset Major Depression
  11. Comparison of Orcinoside With Placebo in Treatment of MDD