Trial · NCT01305408
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
NCT01305408, Phase 3, Completed, Cephalon; results first posted 2015-01-26
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder. Trials, record NCT01305408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01305408
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
- NCT number
- NCT01305408
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 399 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Depression
- Interventions
- Armodafinil, Placebo
- First posted
- 2011-02-28
- Last updated
- 2016-05-26
- Other registries' IDs
- eudract:2010-023623-26
- Results first posted
- 2015-01-26
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Day 0 (baseline), Week 8 | The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. |
| Secondary | Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. |
| Secondary | Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. |
| Secondary | Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. |
| Secondary | Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16) | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. |
| Secondary | Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression. |
| Secondary | Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale | Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks) | The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning. |
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAE) | Day 1 to Week 9 | AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis. |
| Secondary | Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score | Day 0 (baseline), last postbaseline observation (up to 8 weeks) | The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. |
| Secondary | Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score | Day 0 (baseline), last postbaseline observation (up to 8 weeks) | HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity 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 From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Day 0 (baseline), Week 8 | Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16) | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) | Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale | Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks) | Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. | units on a scale | MEAN |
| SECONDARY | Participants With Treatment-Emergent Adverse Events (TEAE) | Day 1 to Week 9 | The safety analysis set includes randomized participants who took 1 or more doses of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score | Day 0 (baseline), last postbaseline observation (up to 8 weeks) | The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score | Day 0 (baseline), last postbaseline observation (up to 8 weeks) | The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments. | units on a scale | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group266
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 Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Placebo | -19.4 | Standard Error 0.99 | units on a scale | |
| Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Armodafinil 150 mg/Day | -20.8 | Standard Error 0.99 | units on a scale | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Placebo | Week 1 (196, 195) | 2 | percentage of participants | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Armodafinil 150 mg/Day | Week 1 (196, 195) | 3 | percentage of participants | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Placebo | Week 2 (187, 189) | 13 | percentage of participants | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Armodafinil 150 mg/Day | Week 2 (187, 189) | 9 | percentage of participants | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Placebo | Week 4 (181, 183) | 21 | percentage of participants | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Armodafinil 150 mg/Day | Week 4 (181, 183) | 27 | percentage of participants | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Placebo | Week 6 (172, 172) | 29 | percentage of participants | |
| Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score | Armodafinil 150 mg/Day | Week 6 (172, 172) | 41 | percentage of participants |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 199 | |
| Overall Study | STARTED | Armodafinil 150 mg/Day | 200 | |
| Overall Study | Safety Population | Placebo | 198 | |
| Overall Study | Safety Population | Armodafinil 150 mg/Day | 200 | |
| Overall Study | Full Analysis Population | Placebo | 196 | |
| Overall Study | Full Analysis Population | Armodafinil 150 mg/Day | 197 | |
| Overall Study | COMPLETED | Placebo | 167 | |
| Overall Study | COMPLETED | Armodafinil 150 mg/Day | 169 | |
| Overall Study | NOT COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Armodafinil 150 mg/Day | 31 |
Source ClinicalTrials.gov
Adverse events30
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 | Nausea | Gastrointestinal disorders | Armodafinil 150 mg/Day | 12 | 200 | 13 |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 198 | 7 |
| other | Headache | Nervous system disorders | Armodafinil 150 mg/Day | 29 | 200 | 35 |
| other | Headache | Nervous system disorders | Placebo | 15 | 198 | 17 |
| serious | Cholecystitis chronic | Hepatobiliary disorders | Armodafinil 150 mg/Day | 1 | 200 | 1 |
| serious | Cholecystitis chronic | Hepatobiliary disorders | Placebo | 0 | 198 | 0 |
| serious | Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Armodafinil 150 mg/Day | 0 | 200 | 0 |
| serious | Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Placebo | 1 | 198 | 1 |
| serious | Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | Armodafinil 150 mg/Day | 0 | 200 | 0 |
| serious | Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 198 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Armodafinil 150 mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Armodafinil 150 mg/Day | 37 | 200 |
| Total, other adverse events | Placebo | 21 | 198 |
| Total, serious adverse events | Armodafinil 150 mg/Day | 5 | 200 |
| Total, serious adverse events | Placebo | 6 | 198 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26330288 | 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 |
|---|
| Armodafinil 150 mg/Day 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.
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