Trial · NCT01725308
A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
NCT01725308, Phase 2, Phase 3, Completed, Astellas Pharma Inc; results first posted 2017-02-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes. Trials, record NCT01725308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01725308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
- NCT number
- NCT01725308
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 431 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Bipolar Disorder
- Interventions
- FK949E, Placebo
- First posted
- 2012-11-12
- Last updated
- 2024-11-15
- Results first posted
- 2017-02-08
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline and Week 8 | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
| Secondary | Change From Baseline in MADRS Total Score (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
| Secondary | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Secondary | Number of Participants With MADRS Response (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
| Secondary | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Secondary | Number of Participants With MADRS Remission (Treatment Period I) | Weeks 1, 2, 3, 4, 6, 8 | MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
| Secondary | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Secondary | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. |
| Secondary | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52 | The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Secondary | Number of Participants With HAM-D17 Response (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline and Week 8 | FAS; Last observation carried forward (LOCF) imputation was used for end of Treatment Period I. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MADRS Total Score (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | FAS; LOCF imputation was used for all time points. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | FAS for combined Treatment Period I and II, which included participants who received at least one dose of FK949E and had measurements taken for at least one efficacy endpoint after the start of FK949E treatment, and with available data at each time point. LOCF imputation method was used at end of combined treatment period. | units on a scale | MEAN |
| SECONDARY | Number of Participants With MADRS Response (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | FAS; LOCF imputation method was used for all time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With MADRS Remission (Treatment Period I) | Weeks 1, 2, 3, 4, 6, 8 | FAS; LOCF imputation method was used for all time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | FAS; LOCF imputation method was used for all time points. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52 | FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period. | units on a scale | MEAN |
| SECONDARY | Number of Participants With HAM-D17 Response (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | FAS; LOCF imputation method was used for all time points. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group1,531
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Placebo | -10.1 | Standard Deviation 10.9 | units on a scale | |
| Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | FK949E 150 mg | -14.4 | Standard Deviation 11.4 | units on a scale | |
| Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | FK949E 300 mg | -12.6 | Standard Deviation 11.4 | units on a scale | |
| Change From Baseline in MADRS Total Score (Treatment Period I) | Placebo | Week 1 | -3.5 | Standard Deviation 5.4 | units on a scale |
| Change From Baseline in MADRS Total Score (Treatment Period I) | FK949E 150 mg | Week 1 | -6.4 | Standard Deviation 8.1 | units on a scale |
| Change From Baseline in MADRS Total Score (Treatment Period I) | FK949E 300 mg | Week 1 | -5.1 | Standard Deviation 6.8 | units on a scale |
| Change From Baseline in MADRS Total Score (Treatment Period I) | Placebo | Week 2 | -5.1 | Standard Deviation 7.0 | units on a scale |
| Change From Baseline in MADRS Total Score (Treatment Period I) | FK949E 150 mg | Week 2 | -10.0 | Standard Deviation 8.9 | units on a scale |
| Change From Baseline in MADRS Total Score (Treatment Period I) | FK949E 300 mg | Week 2 | -8.3 | Standard Deviation 8.6 | units on a scale |
| Change From Baseline in MADRS Total Score (Treatment Period I) | Placebo | Week 3 | -7.1 | Standard Deviation 8.8 | units on a scale |
1 to 10 of 1,531Source ClinicalTrials.gov
See all 1,531 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period I | STARTED | Placebo / FK949E | 178 | |
| Treatment Period I | STARTED | FK949E 150 mg / FK949E | 74 | |
| Treatment Period I | STARTED | FK949E 300 mg / FK949E | 179 | |
| Treatment Period I | Treated | Placebo / FK949E | 177 | |
| Treatment Period I | Treated | FK949E 150 mg / FK949E | 74 | |
| Treatment Period I | Treated | FK949E 300 mg / FK949E | 179 | |
| Treatment Period I | COMPLETED | Placebo / FK949E | 134 | |
| Treatment Period I | COMPLETED | FK949E 150 mg / FK949E | 60 | |
| Treatment Period I | COMPLETED | FK949E 300 mg / FK949E | 138 | |
| Treatment Period I | NOT COMPLETED | Placebo / FK949E | 44 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events456
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 | Palpitation | Cardiac disorders | Treatment Period I: Placebo | 2 | 177 | |
| other | Palpitation | Cardiac disorders | Treatment Period I: FK949E 150 mg | 2 | 74 | |
| other | Palpitation | Cardiac disorders | Treatment Period I: FK949E 300 mg | 0 | 179 | |
| other | Palpitation | Cardiac disorders | Treatment Period I + II: Placebo / FK949E | 2 | 120 | |
| other | Palpitation | Cardiac disorders | Treatment Period I + II: FK949E 150 mg / FK949E | 3 | 74 | |
| other | Palpitation | Cardiac disorders | Treatment Period I + II: FK949E 300 mg / FK949E | 1 | 179 | |
| other | Tachycardia | Cardiac disorders | Treatment Period I: Placebo | 0 | 177 | |
| other | Tachycardia | Cardiac disorders | Treatment Period I: FK949E 150 mg | 1 | 74 | |
| other | Tachycardia | Cardiac disorders | Treatment Period I: FK949E 300 mg | 2 | 179 | |
| other | Tachycardia | Cardiac disorders | Treatment Period I + II: Placebo / FK949E | 6 | 120 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Period I: Placebo | 2 | 177 |
| Total, all-cause mortality | Treatment Period I: FK949E 150 mg | 0 | 74 |
| Total, all-cause mortality | Treatment Period I: FK949E 300 mg | 0 | 179 |
| Total, all-cause mortality | Treatment Period I + II: Placebo / FK949E | 0 | 120 |
| Total, all-cause mortality | Treatment Period I + II: FK949E 150 mg / FK949E | 0 | 74 |
| Total, all-cause mortality | Treatment Period I + II: FK949E 300 mg / FK949E | 0 | 179 |
| Total, other adverse events | Treatment Period I: Placebo | 62 | 177 |
| Total, other adverse events | Treatment Period I: FK949E 150 mg | 51 | 74 |
| Total, other adverse events | Treatment Period I: FK949E 300 mg | 140 | 179 |
| Total, other adverse events | Treatment Period I + II: Placebo / FK949E | 106 | 120 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01725308
GET https://conductscience.org/api/trials/v1/NCT01725308/registered?page=2