Trial · NCT01152554
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
NCT01152554, Phase 3, Completed, AstraZeneca; results first posted 2012-10-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder. Trials, record NCT01152554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01152554
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
- NCT number
- NCT01152554
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 813 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Major Depressive Disorder, MDD, Depression
- Interventions
- TC-5214, Placebo
- First posted
- 2010-06-29
- Last updated
- 2014-04-11
- Results first posted
- 2012-10-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Patients Experiencing at Least One Adverse Event (AE) | Randomization (Week 0) to end of the follow-up period (Week 54) | The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated. |
| Primary | Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | Randomization (Week 0) to end of the follow-up period (Week 54) | The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. |
| Primary | Frequency of Patients Experiencing Serious Adverse Events (SAEs) | Randomization (Week 0) to end of the follow-up period (Week 54) | The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated. |
| 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 | Week 12 to Week 24 | The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score \>12 but ≤16 or missing was allowed from Week 16 to Week 20. A 10-item scale for the evaluation of depressive symptoms. Each 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. |
| 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 | Week 12 to Week 52 | The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS \>12 but ≤16 or missing were allowed from Week 16 to Week 48. A 10-item scale for the evaluation of depressive symptoms. Each 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. |
| 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) | Randomization (Week 0) to end of treatment (Week 52) | A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity. |
| 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 | Randomization (Week 0) to end of treatment (Week 52) | Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired). |
| 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 | Randomization (Week 0) to end of treatment (Week 52) | The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%. |
| Secondary | Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52) | Randomization (Week 0) to end of treatment (Week 52) | A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Patients Experiencing at Least One Adverse Event (AE) | Randomization (Week 0) to end of the follow-up period (Week 54) | Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available. | percentage of participants analyzed | NUMBER |
| PRIMARY | Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | Randomization (Week 0) to end of the follow-up period (Week 54) | Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available. | percentage of participants analyzed | NUMBER |
| PRIMARY | Frequency of Patients Experiencing Serious Adverse Events (SAEs) | Randomization (Week 0) to end of the follow-up period (Week 54) | Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available. | percentage of participants analyzed | NUMBER |
| 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 | Week 12 to Week 24 | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | percentage of participants analyzed | NUMBER |
| 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 | Week 12 to Week 52 | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | percentage of patients analyzed | NUMBER |
| 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) | Randomization (Week 0) to end of treatment (Week 52) | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | units on a scale | MEAN |
| 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 | Randomization (Week 0) to end of treatment (Week 52) | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | units on a scale | MEAN |
| 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 | Randomization (Week 0) to end of treatment (Week 52) | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | units on a scale | MEAN |
| SECONDARY | Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52) | Randomization (Week 0) to end of treatment (Week 52) | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Patients Experiencing at Least One Adverse Event (AE) | TC-5214 | 82.4 | percentage of participants analyzed | ||
| Frequency of Patients Experiencing at Least One Adverse Event (AE) | Placebo | 84.6 | percentage of participants analyzed | ||
| Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | TC-5214 | 10.5 | percentage of participants analyzed | ||
| Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | Placebo | 7.0 | percentage of participants analyzed | ||
| Frequency of Patients Experiencing Serious Adverse Events (SAEs) | TC-5214 | 3.6 | percentage of participants analyzed | ||
| Frequency of Patients Experiencing Serious Adverse Events (SAEs) | Placebo | 2.5 | percentage of participants analyzed | ||
| 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 | TC-5214 | 18.2 | percentage of participants analyzed | ||
| 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 | Placebo | 20.6 | percentage of participants analyzed | ||
| 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 | TC-5214 | 9.7 | percentage of patients analyzed | ||
| 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 | Placebo | 12.5 | percentage of patients analyzed |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TC-5214 | 610 | |
| Overall Study | STARTED | Placebo | 203 | |
| Overall Study | Received Treatment | TC-5214 | 607 | |
| Overall Study | Received Treatment | Placebo | 201 | |
| Overall Study | COMPLETED | TC-5214 | 276 | |
| Overall Study | COMPLETED | Placebo | 92 | |
| Overall Study | NOT COMPLETED | TC-5214 | 334 | |
| Overall Study | NOT COMPLETED | Placebo | 111 |
Source ClinicalTrials.gov
Adverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo | 12 | 201 | 14 |
| other | Constipation | Gastrointestinal disorders | TC-5214 | 120 | 607 | 147 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 20 | 201 | 23 |
| other | Diarrhoea | Gastrointestinal disorders | TC-5214 | 65 | 607 | 80 |
| other | Nausea | Gastrointestinal disorders | Placebo | 24 | 201 | 27 |
| other | Nausea | Gastrointestinal disorders | TC-5214 | 64 | 607 | 79 |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 10 | 201 | 11 |
| other | Dry Mouth | Gastrointestinal disorders | TC-5214 | 59 | 607 | 61 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 13 | 201 | 21 |
| other | Vomiting | Gastrointestinal disorders | TC-5214 | 32 | 607 | 40 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | TC-5214 | ||
| Total, other adverse events | Placebo | 151 | 201 |
| Total, other adverse events | TC-5214 | 451 | 607 |
| Total, serious adverse events | Placebo | 5 | 201 |
| Total, serious adverse events | TC-5214 | 22 | 607 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25514064 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| TC-5214 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01152554
GET https://conductscience.org/api/trials/v1/NCT01152554/events?page=2