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Trial record 56 of 1948 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Major Depressive Disorder

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

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ClinicalTrials.gov Identifier: NCT01288079
Recruitment Status : Terminated
First Posted : February 2, 2011
Results First Posted : October 29, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 26, 2011
First Posted Date  ICMJE February 2, 2011
Results First Submitted Date  ICMJE August 7, 2012
Results First Posted Date  ICMJE October 29, 2012
Last Update Posted Date November 20, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
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) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
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. ]
Change History Complete list of historical versions of study NCT01288079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
  • Changes in clinician rated symptoms as assessed by MADRS [ Time Frame: Range of weeks 8 (baseline) to 16. ]
  • Changes in patient-reported outcomes as assessed by Sheehan Disability Scale (SDS) [ Time Frame: Range of weeks 8 (baseline) and 16 ]
  • 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 ]
  • Change in physical exam results, vital signs, lab tests (incl. ECG (electrocardiogram) will be assessed. [ Time Frame: Range of weeks 1-18. ]
  • Changes in clinician rated symptoms as assessed by Hamilton Rating Scale for Depression (HAMD). [ Time Frame: Range of weeks 8 (baseline) to 16. ]
  • Changes in clinician rated symptoms as assessed by Clinical Global Impression-Severity (CGI-S) [ Time Frame: Range of weeks 8 (baseline) to 16. ]
  • Changes in clinician rated symptoms as assessed by Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Range of weeks 8 (baseline) to 16. ]
  • Changes in clinician rated symptoms as assessed by Hamilton Anxiety Assessment (HAM-A). [ Time Frame: Range of weeks 8 (baseline) to 16. ]
  • Changes in patient-reported outcomes as assessed by European Quality of Life (EQ-5D). [ Time Frame: Range of weeks 8 (baseline) to 16. ]
  • Changes in CSFQ (Changes Sexual Functioning Questionnaire) will be assessed. [ Time Frame: Range of weeks 1-18 ]
  • Changes in DESS (Discontinuation Emergent Signs and Symptoms) will be assessed. [ Time Frame: Range of weeks 1-18 ]
  • Changes in C-SSRS (Columbia Suicide Severity Rating Scale) will be assessed. [ Time Frame: Range of weeks 1-18 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 27, 2012)
145
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2011)
352
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   Finland,   India,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01288079
Other Study ID Numbers  ICMJE D4131C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hans A Eriksson, MD, PhD, MBA AstraZeneca R&D Södertälje
PRS Account AstraZeneca
Verification Date November 2012

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