Phase 3
Completed N=319
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT01157078 ↗Enrolled (actual)
319
Serious AEs
0.3%
Results posted
Nov 2012
Primary outcomePrimary: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. — -12.7; -11.7 units on a scale — p=0.349
Summary
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. |
-12.7; -11.7 | 0.349 |
| SECONDARY Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16) |
42.0; 47.0 | 0.444 |
| SECONDARY Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16) |
30.5; 24.2 | 0.130 |
| SECONDARY Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16) |
6.0; 3.9 | 0.307 |
| SECONDARY Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16) |
14.2; 11.8 | 0.313 |
| SECONDARY Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16) |
9.5; 6.5 | 0.201 |
| SECONDARY Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score |
-9.7; -9.3 | 0.552 |
| SECONDARY Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16) |
-1.4; -1.3 | 0.803 |
| SECONDARY Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of "Very Much Improved" or "Much Improved" From Randomization (Week 8) to End of Treatment (Week 16) |
56.3; 51.0 | 0.440 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 9 |
-3.6; -3.8 | 0.768 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 10 |
-6.1; -6.8 | 0.373 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 12 |
-8.7; -8.0 | 0.435 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 14 |
-11.1; -10.5 | 0.501 |
| SECONDARY Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score |
-6.09; -5.47 | 0.424 |
| SECONDARY Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score |
-2.0; -1.7 | 0.214 |
| SECONDARY Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score |
-1.9; -1.9 | 0.931 |
| SECONDARY Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score |
-2.1; -2.0 | 0.755 |
| SECONDARY Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score |
12.47; 11.65 | 0.646 |
| SECONDARY Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15 |
0.2; 0.3 | 0.446 |
| SECONDARY Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16 |
0.7; 0.5 | 0.178 |
| SECONDARY Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16) |
-12.6; -11.5 | 0.515 |
| SECONDARY Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16) |
0.113; 0.089; 13.3; 11.6 | 0.298 |
Eligibility Criteria
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.
- Out-patient 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.
- History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population
Data sourced from ClinicalTrials.gov (NCT01157078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.