Phase 3
Completed N=813
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Major Depressive Disorder · MDD · Depression
Source: ClinicalTrials.gov NCT01152554 ↗
Enrolled (actual)
813
Serious AEs
3.3%
Results posted
Oct 2012
Primary outcomePrimary: Frequency of Patients Experiencing at Least One Adverse Event (AE) — 82.4; 84.6 percentage of participants analyzed
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 for 52 weeks with another antidepressant medicine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Patients Experiencing at Least One Adverse Event (AE) |
82.4; 84.6 | — |
| PRIMARY Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) |
10.5; 7.0 | — |
| PRIMARY Frequency of Patients Experiencing Serious Adverse Events (SAEs) |
3.6; 2.5 | — |
| SECONDARY Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24 |
18.2; 20.6 | 0.697 |
| SECONDARY Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52 |
9.7; 12.5 | 0.582 |
| SECONDARY Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52) |
-1.8; -1.6 | — |
| SECONDARY Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score |
-6.98; -7.44 | — |
| SECONDARY Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score |
10.83; 11.62 | — |
| SECONDARY Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52) |
0.081; 0.071; 8.7; 11.9 | — |
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.
- Patients with significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
Data sourced from ClinicalTrials.gov (NCT01152554). 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.