A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

Phase 2

Terminated

• Conditions: Major Depressive Disorder
• Interventions: Drug: TC-5214; Drug: Duloxetine; Drug: Placebo

• Registration Number: NCT01288079
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2012-08-07
• Results First Submitted QC: 2012-09-27
• Results First Posted: 2012-10-29
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-14
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Provision of signed and dated informed consent before initiation of any study-related procedures.
• The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
• Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
• Outpatient status at enrollment and randomization.

Exclusion Criteria

• Patients with a lifetime history of bipolar disorder; psychotic disorder or post-traumatic stress disorder.
• Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
• Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
• History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
• Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TC-5214	TC-5214, 1 mg BID
3	Duloxetine	Duloxetine 60 mg Q Day
4	Placebo	Placebo
2	TC-5214	TC-5214, 4 mg BID

Primary Outcome Measures

Name	Time	Method
Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment	Randomization (Week 8) to end of treatment (Week 16)	A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Kumamoto, Japan