Trial · NCT01153347
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
NCT01153347, Phase 3, Completed, AstraZeneca; results first posted 2012-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder. Trials, record NCT01153347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01153347
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
- NCT number
- NCT01153347
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,409 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Major Depressive Disorder, Depression
- Interventions
- TC-5214, Placebo
- First posted
- 2010-06-30
- Last updated
- 2014-04-11
- Results first posted
- 2012-11-20
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. | Randomization (Week 8) to end of treatment (Week 16) | 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 | 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) | Randomization (Week 8) to end of treatment (Week 16) | The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated. 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 | Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16) | Week 16 | The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated. 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 | 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) | Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16 | The percentage of patients with 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) was calculated. 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 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) | Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16 | The percentage of patients with 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) was calculated. 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 Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16) | Week 12, Week 14, Week 16 | The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated. 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 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 | Randomization (Week 8) to end of treatment (Week 16) | A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. |
| 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) | Randomization (Week 8) to end of treatment (Week 16) | 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 | 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) | Randomization (Week 8) to end of treatment (Week 16) | 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. CGI-I scores \>4 indicate worsening, while scores \<4 indicate improvement. |
| Secondary | Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16) | Randomization (Week 8) to end of treatment (Week 16) | A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale, the total score can range from 0 to 56. Higher HAM-A scores indicate higher levels of anxiety. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. | Randomization (Week 8) to end of treatment (Week 16) | 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 randomization and at least 1 post-randomization MADRS total score. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | Randomization (Week 8) to end of treatment (Week 16) | 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 randomization and at least 1 post-randomization MADRS total score. | percentage of participants analyzed | NUMBER |
| SECONDARY | Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16) | Week 16 | 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 randomization and at least 1 post-randomization MADRS total score. | percentage of participants analyzed | NUMBER |
| 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) | Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16 | 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 randomization and at least 1 post-randomization MADRS total score. | percentage of participants analyzed | NUMBER |
| 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) | Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16 | 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 randomization and at least 1 post-randomization MADRS total score. | percentage of patients analyzed | NUMBER |
| SECONDARY | Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16) | Week 12, Week 14, Week 16 | 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 randomization and at least 1 post-randomization MADRS total score. | percentage of participants analyzed | NUMBER |
| 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 | Randomization (Week 8) to end of treatment (Week 16) | 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 randomization and at least 1 post-randomization MADRS total score. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | Randomization (Week 8) to end of treatment (Week 16) | 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 randomization and at least 1 post-randomization MADRS total score. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | Randomization (Week 8) to end of treatment (Week 16) | 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 randomization and at least 1 post-randomization MADRS total score. | percentage of participants analyzed | NUMBER |
| SECONDARY | Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16) | Randomization (Week 8) to end of treatment (Week 16) | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. | 0.5 mg BID TC-5214 | -12.1 | Standard Error 0.81 | units on a scale | |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. | 2 mg BID TC-5214 | -11.8 | Standard Error 0.83 | units on a scale | |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. | 4 mg BID TC-5214 | -11.3 | Standard Error 0.84 | units on a scale | |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment. | Placebo | -11.2 | Standard Error 0.80 | units on a scale | |
| 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) | 0.5 mg BID TC-5214 | 43.9 | percentage of participants analyzed | ||
| 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) | 2 mg BID TC-5214 | 39.7 | percentage of participants analyzed | ||
| 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) | 4 mg BID TC-5214 | 38.8 | percentage of participants analyzed | ||
| 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) | Placebo | 42.7 | percentage of participants analyzed | ||
| Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16) | 0.5 mg BID TC-5214 | 29.0 | percentage of participants analyzed | ||
| Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16) | 2 mg BID TC-5214 | 26.9 | percentage of participants analyzed |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5 mg BID TC-5214 | 160 | |
| Overall Study | STARTED | 2 mg BID TC-5214 | 160 | |
| Overall Study | STARTED | 4 mg BID TC-5214 | 160 | |
| Overall Study | STARTED | Placebo | 161 | |
| Overall Study | Received Treatment | 0.5 mg BID TC-5214 | 160 | |
| Overall Study | Received Treatment | 2 mg BID TC-5214 | 158 | |
| Overall Study | Received Treatment | 4 mg BID TC-5214 | 158 | |
| Overall Study | Received Treatment | Placebo | 160 | |
| Overall Study | COMPLETED | 0.5 mg BID TC-5214 | 127 | |
| Overall Study | COMPLETED | 2 mg BID TC-5214 | 116 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events192
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 | Vision Blurred | Eye disorders | Placebo | 0 | 160 | 0 |
| other | Vision Blurred | Eye disorders | 0.5 mg BID TC-5214 | 1 | 160 | 1 |
| other | Vision Blurred | Eye disorders | 2 mg BID TC-5214 | 3 | 158 | 3 |
| other | Vision Blurred | Eye disorders | 4 mg BID TC-5214 | 6 | 158 | 7 |
| other | Constipation | Gastrointestinal disorders | Placebo | 7 | 160 | 8 |
| other | Constipation | Gastrointestinal disorders | 0.5 mg BID TC-5214 | 12 | 160 | 13 |
| other | Constipation | Gastrointestinal disorders | 2 mg BID TC-5214 | 25 | 158 | 28 |
| other | Constipation | Gastrointestinal disorders | 4 mg BID TC-5214 | 45 | 158 | 48 |
| other | Nausea | Gastrointestinal disorders | Placebo | 10 | 160 | 11 |
| other | Nausea | Gastrointestinal disorders | 0.5 mg BID TC-5214 | 7 | 160 | 7 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 0.5 mg BID TC-5214 | ||
| Total, all-cause mortality | 2 mg BID TC-5214 | ||
| Total, all-cause mortality | 4 mg BID TC-5214 | ||
| Total, other adverse events | Placebo | 76 | 160 |
| Total, other adverse events | 0.5 mg BID TC-5214 | 80 | 160 |
| Total, other adverse events | 2 mg BID TC-5214 | 88 | 158 |
| Total, other adverse events | 4 mg BID TC-5214 | 99 | 158 |
| Total, serious adverse events | Placebo | 2 | 160 |
| Total, serious adverse events | 0.5 mg BID TC-5214 | 2 | 160 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25602163 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01153347
GET https://conductscience.org/api/trials/v1/NCT01153347/registered?page=2