Phase 3
Completed N=641
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT01153347 ↗Enrolled (actual)
641
Serious AEs
1.4%
Results posted
Nov 2012
Primary outcomePrimary: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. — -12.1; -11.8; -11.3; -11.2 units on a scale — p=1.000
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. |
-12.1; -11.8; -11.3; -11.2 | 1.000 |
| 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) |
43.9; 39.7; 38.8; 42.7 | 0.967 |
| SECONDARY Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16) |
29.0; 26.9; 23.7; 29.9 | 0.730 |
| 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) |
8.8; 7.8; 8.3; 8.5 | 0.905 |
| 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) |
15.9; 18.7; 14.0; 15.9 | 0.778 |
| SECONDARY Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16) |
10.3; 12.7; 7.6; 9.2 | 0.949 |
| 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 |
-10.1; -9.7; -9.5; -9.1 | 0.207 |
| 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) |
-1.3; -1.3; -1.2; -1.2 | 0.551 |
| 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) |
48.4; 49.4; 37.5; 47.8 | 0.908 |
| SECONDARY Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16) |
-7.07; -6.46; -6.75; -6.24 | 0.202 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 9 |
-4.0; -5.1; -4.0; -5.0 | 0.097 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 10 |
-6.3; -6.9; -7.3; -7.1 | 0.303 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 12 |
-9.4; -9.4; -8.9; -8.5 | 0.339 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 14 |
-11.0; -11.3; -10.6; -10.7 | 0.737 |
| 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 |
-5.53; -5.45; -4.53; -4.93 | 1.000 |
| SECONDARY Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score |
-1.7; -1.8; -1.7; -1.7 | 0.953 |
| 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; -1.6; -1.9 | 0.915 |
| 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 |
-1.9; -1.8; -1.6; -1.6 | 0.213 |
| 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 |
12.81; 11.42; 8.83; 10.71 | 0.215 |
| 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 |
0.3; 0.4; 0.2; 0.4 | 0.412 |
| 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 |
0.6; 0.5; 0.4; 0.5 | 0.353 |
| SECONDARY Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16) |
0.114; 0.107; 0.106; 0.120; 13.4; 12.9 | 0.747 |
| 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) |
-10.2; -10.1; -8.3; -8.8 | 0.350 |
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.
- 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.
- History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.
Data sourced from ClinicalTrials.gov (NCT01153347). 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.