Phase 3
Completed N=696
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.
Source: ClinicalTrials.gov NCT01197508 ↗Enrolled (actual)
696
Serious AEs
1.4%
Results posted
Oct 2012
Primary outcomePrimary: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. — -11.6; -12.2; -12.2; -12.7 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 a 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. |
-11.6; -12.2; -12.2; -12.7 | 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) |
48.6; 51.1; 41.2; 54.0 | 0.144 |
| SECONDARY Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16) |
37.0; 35.1; 30.0; 39.1 | 0.636 |
| 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) |
7.5; 8.1; 9.6; 9.2 | 0.711 |
| 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) |
14.7; 19.3; 15.3; 23.7 | 0.037 sig |
| SECONDARY Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16) |
10.6; 10.5; 8.0; 12.1 | 0.913 |
| 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 |
-10.07; -10.21; -9.07; -11.16 | 0.120 |
| 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) |
-1.5; -1.6; -1.7; -1.7 | 0.131 |
| 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) |
59.5; 62.1; 58.8; 67.8 | 0.046 sig |
| SECONDARY Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16) |
-8.5; -8.6; -8.1; -9.3 | 0.273 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 9 |
-3.0; -3.0; -2.6; -3.2 | 0.590 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 10 |
-4.8; -5.9; -5.0; -6.0 | 0.052 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 12 |
-8.1; -8.5; -7.8; -8.7 | 0.394 |
| SECONDARY Change in MADRS Total Score From Randomization (Week 8) to Week 14 |
-9.5; -10.6; -9.6; -11.0 | 0.046 sig |
| 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 |
-6.08; -6.34; -6.21; -7.06 | 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 |
-2.0; -1.8; -1.9; -2.1 | 0.914 |
| SECONDARY Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score |
-2.1; -2.2; -2.2; -2.4 | 0.248 |
| 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 |
-2.0; -2.1; -2.0; -2.3 | 0.174 |
| 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 |
13.08; 13.24; 11.84; 14.55 | 0.371 |
| 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 |
0.6; 0.7; 0.5; 0.7 | 0.312 |
| 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; 0.7; 0.6; 0.8 | 0.152 |
| SECONDARY Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16) |
0.128; 0.139; 0.133; 0.139; 16.4; 17.0 | 0.543 |
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 (NCT01197508). 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.