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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01288079
First received: January 26, 2011
Last updated: November 14, 2012
Last verified: November 2012

January 26, 2011
November 14, 2012
February 2011
August 2012   (final data collection date for primary outcome measure)
Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment [ Time Frame: Randomization (Week 8) to end of treatment (Week 16) ] [ Designated as safety issue: No ]
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.
Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16) [ Time Frame: Range of weeks 8 (baseline) to 16. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01288079 on ClinicalTrials.gov Archive Site
Not Provided
  • Changes in clinician rated symptoms as assessed by MADRS [ Time Frame: Range of weeks 8 (baseline) to 16. ] [ Designated as safety issue: No ]
  • Changes in patient-reported outcomes as assessed by Sheehan Disability Scale (SDS) [ Time Frame: Range of weeks 8 (baseline) and 16 ] [ Designated as safety issue: No ]
  • Adverse Events (AEs)(any incidence) and Serious Adverse Events (SAEs), will be assessed as a measure of safety and tolerability. [ Time Frame: Range of weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Change in physical exam results, vital signs, lab tests (incl. ECG (electrocardiogram) will be assessed. [ Time Frame: Range of weeks 1-18. ] [ Designated as safety issue: Yes ]
  • Changes in clinician rated symptoms as assessed by Hamilton Rating Scale for Depression (HAMD). [ Time Frame: Range of weeks 8 (baseline) to 16. ] [ Designated as safety issue: No ]
  • Changes in clinician rated symptoms as assessed by Clinical Global Impression-Severity (CGI-S) [ Time Frame: Range of weeks 8 (baseline) to 16. ] [ Designated as safety issue: No ]
  • Changes in clinician rated symptoms as assessed by Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Range of weeks 8 (baseline) to 16. ] [ Designated as safety issue: No ]
  • Changes in clinician rated symptoms as assessed by Hamilton Anxiety Assessment (HAM-A). [ Time Frame: Range of weeks 8 (baseline) to 16. ] [ Designated as safety issue: No ]
  • Changes in patient-reported outcomes as assessed by European Quality of Life (EQ-5D). [ Time Frame: Range of weeks 8 (baseline) to 16. ] [ Designated as safety issue: No ]
  • Changes in CSFQ (Changes Sexual Functioning Questionnaire) will be assessed. [ Time Frame: Range of weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Changes in DESS (Discontinuation Emergent Signs and Symptoms) will be assessed. [ Time Frame: Range of weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Changes in C-SSRS (Columbia Suicide Severity Rating Scale) will be assessed. [ Time Frame: Range of weeks 1-18 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: TC-5214
    Tablet, oral, twice daily for 8 weeks
  • Drug: Duloxetine
    Capsule, oral, once daily
  • Drug: Placebo
    Tablet, oral, twice daily for 8 weeks
  • Experimental: 1
    TC-5214, 1 mg BID
    Intervention: Drug: TC-5214
  • Experimental: 2
    TC-5214, 4 mg BID
    Intervention: Drug: TC-5214
  • Active Comparator: 3
    Duloxetine 60 mg Q Day
    Intervention: Drug: Duloxetine
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
145
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Estonia,   Finland,   India,   Japan
 
NCT01288079
D4131C00001
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Hans A Eriksson, MD, PhD, MBA AstraZeneca R&D Södertälje
AstraZeneca
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP