Trial · NCT00481195
Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
NCT00481195, Phase 2, Completed, Cephalon; results first posted 2010-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder. Trials, record NCT00481195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00481195
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
- NCT number
- NCT00481195
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 257 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Bipolar I Depression
- Interventions
- Armodafinil, Placebo
- First posted
- 2007-06-01
- Last updated
- 2013-07-19
- Results first posted
- 2010-12-20
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 8 weeks from start of study drug administration (or last observation after baseline) | The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30. |
| Secondary | The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 1 week following the start of study drug administration | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30. |
| Secondary | The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 2 weeks following the start of study drug administration | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30. |
| Secondary | The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 3 weeks following the start of study drug administration | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30. |
| Secondary | The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 4 weeks following the start of study drug administration | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30. |
| Secondary | The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 6 weeks following the start of study drug administration | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30. |
| Secondary | The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 8 weeks following the start of study drug administration | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30. |
| Secondary | Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score \<=11). |
| Secondary | Number of Patients Achieving "Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "response" (\> 50% decrease from baseline in total score). |
| Secondary | Number of Patients Achieving "Sustained Remission" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) | The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "sustained remission" (total score \<= 11 that persists over the four week period from Week 4 to Week 8). |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 8 weeks from start of study drug administration (or last observation after baseline) | Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at least one time point after baseline | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 1 week following the start of study drug administration | Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at week 1 after start of study drug administration | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 2 weeks following the start of study drug administration | Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 2 weeks | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 3 weeks following the start of study drug administration | Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 3 weeks | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 4 weeks following the start of study drug administration | Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 4 weeks | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 6 weeks following the start of study drug administration | Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 6 weeks | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Baseline and 8 weeks following the start of study drug administration | Full analysis set defined as subjects who were assessed at baseline and at 8 weeks with the IDS-C30. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) | Full analysis set defined as subjects who had completed IDS-C30 at baseline and at least one observation after baseline | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) | Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) | Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline | Participants | NUMBER |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Armodafinil 150 mg/Day | -15.6 | Standard Error 1.32 | Units on a scale | |
| The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Placebo | -12.5 | Standard Error 1.34 | Units on a scale | |
| The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Armodafinil 150 mg/Day | -6.5 | Standard Error 0.84 | Units on a scale | |
| The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Placebo | -4.8 | Standard Error 0.85 | Units on a scale | |
| The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Armodafinil 150 mg/Day | -10.0 | Standard Error 1.04 | Units on a scale | |
| The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Placebo | -7.3 | Standard Error 1.05 | Units on a scale | |
| The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Armodafinil 150 mg/Day | -13.1 | Standard Error 1.16 | Units on a scale | |
| The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Placebo | -10.7 | Standard Error 1.20 | Units on a scale | |
| The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Armodafinil 150 mg/Day | -13.7 | Standard Error 1.19 | Units on a scale | |
| The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) | Placebo | -12.1 | Standard Error 1.25 | Units on a scale |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Armodafinil 150 mg/Day | 128 | |
| Overall Study | STARTED | Placebo | 129 | |
| Overall Study | COMPLETED | Armodafinil 150 mg/Day | 89 | |
| Overall Study | COMPLETED | Placebo | 90 | |
| Overall Study | NOT COMPLETED | Armodafinil 150 mg/Day | 39 | |
| Overall Study | NOT COMPLETED | Placebo | 39 |
Source ClinicalTrials.gov
Adverse events44
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 | Diarrhoea | Gastrointestinal disorders | Armodafinil 150 mg/Day | 12 | 126 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 8 | 125 | |
| other | Nausea | Gastrointestinal disorders | Armodafinil 150 mg/Day | 9 | 126 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 125 | |
| other | Dry Mouth | Gastrointestinal disorders | Armodafinil 150 mg/Day | 8 | 126 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 5 | 125 | |
| other | Vomiting | Gastrointestinal disorders | Armodafinil 150 mg/Day | 5 | 126 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 4 | 125 | |
| other | Toothache | Gastrointestinal disorders | Armodafinil 150 mg/Day | 1 | 126 | |
| other | Toothache | Gastrointestinal disorders | Placebo | 5 | 125 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 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 | 56 | 126 |
| Total, other adverse events | Placebo | 54 | 125 |
| Total, serious adverse events | Armodafinil 150 mg/Day | 3 | 126 |
| Total, serious adverse events | Placebo | 3 | 125 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20673554 | 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.
GET https://conductscience.org/api/trials/v1/NCT00481195
GET https://conductscience.org/api/trials/v1/NCT00481195/registered?page=2