Trial · NCT01687478
A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression
NCT01687478, Phase 3, Terminated, Eli Lilly and Company; results first posted 2017-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression. Trials, record NCT01687478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01687478
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression
- NCT number
- NCT01687478
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 176 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Treatment Resistant Depression
- Interventions
- Olanzapine, Fluoxetine, Placebo
- First posted
- 2012-09-19
- Last updated
- 2019-10-09
- Results first posted
- 2017-08-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS) | Baseline, 8 Weeks | The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)\*Visit. |
| Secondary | Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale | Baseline, 8 Weeks | CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)\*Visit. |
| Secondary | Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS) | Baseline, 8 Weeks | SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms. |
| Secondary | Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36) | Baseline, 8 Weeks | SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning. |
| Secondary | Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS) | Baseline, 8 Weeks | SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption. |
| Secondary | Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score | Baseline,8 Weeks | The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. |
| Secondary | Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks | Baseline, 8 Weeks | The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. |
| Secondary | Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS) | Baseline, 8 Weeks | BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results. |
| Secondary | Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS) | Baseline, 8 Weeks | AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements. |
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 | Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS) | Baseline, 8 Weeks | Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale | Baseline, 8 Weeks | Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS) | Baseline, 8 Weeks | All randomized participants who received at least one dose of study drug. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36) | Baseline, 8 Weeks | All randomized participants. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS) | Baseline, 8 Weeks | All randomized participants. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score | Baseline,8 Weeks | All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement. | Percent of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks | Baseline, 8 Weeks | All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement. | Percent of participants | NUMBER |
| SECONDARY | Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS) | Baseline, 8 Weeks | All randomized participants who received at least one dose of study drug. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS) | Baseline, 8 Weeks | All randomized participants who received at least one dose of study drug. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS) | Olanzapine + Fluoxetine | -15.92 | Standard Error 1.20 | Units on a scale | |
| Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS) | Placebo + Fluoxetine | -14.30 | Standard Error 1.28 | Units on a scale | |
| Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale | Olanzapine + Fluoxetine | -1.43 | Standard Error 0.15 | Units on a scale | |
| Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale | Placebo + Fluoxetine | -1.63 | Standard Error 0.16 | Units on a scale | |
| Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS) | Olanzapine + Fluoxetine | 0.03 | Standard Deviation 1.71 | units on a scale | |
| Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS) | Placebo + Fluoxetine | -0.14 | Standard Deviation 1.72 | units on a scale | |
| Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36) | Olanzapine + Fluoxetine | Physical Functioning | 2.20 | Standard Deviation 7.51 | units on a scale |
| Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36) | Placebo + Fluoxetine | Physical Functioning | 0.70 | Standard Deviation 7.47 | units on a scale |
| Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36) | Olanzapine + Fluoxetine | Role-Physical | 3.99 | Standard Deviation 11.79 | units on a scale |
| Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36) | Placebo + Fluoxetine | Role-Physical | 3.93 | Standard Deviation 11.23 | units on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olanzapine + Fluoxetine | 88 | |
| Overall Study | STARTED | Placebo + Fluoxetine | 88 | |
| Overall Study | Safety Analysis Set | Olanzapine + Fluoxetine | 88 | |
| Overall Study | Safety Analysis Set | Placebo + Fluoxetine | 87 | |
| Overall Study | COMPLETED | Olanzapine + Fluoxetine | 56 | |
| Overall Study | COMPLETED | Placebo + Fluoxetine | 49 | |
| Overall Study | NOT COMPLETED | Olanzapine + Fluoxetine | 32 | |
| Overall Study | NOT COMPLETED | Placebo + Fluoxetine | 39 |
Source ClinicalTrials.gov
Adverse events172
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 | Angina pectoris | Cardiac disorders | Olanzapine + Fluoxetine | 1 | 88 | 1 |
| other | Angina pectoris | Cardiac disorders | Placebo + Fluoxetine | 0 | 87 | 0 |
| other | Cardiovascular insufficiency | Cardiac disorders | Olanzapine + Fluoxetine | 1 | 88 | 1 |
| other | Cardiovascular insufficiency | Cardiac disorders | Placebo + Fluoxetine | 0 | 87 | 0 |
| other | Palpitations | Cardiac disorders | Olanzapine + Fluoxetine | 1 | 88 | 1 |
| other | Palpitations | Cardiac disorders | Placebo + Fluoxetine | 2 | 87 | 2 |
| other | Sinus bradycardia | Cardiac disorders | Olanzapine + Fluoxetine | 0 | 88 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Placebo + Fluoxetine | 1 | 87 | 1 |
| other | Supraventricular extrasystoles | Cardiac disorders | Olanzapine + Fluoxetine | 0 | 88 | 0 |
| other | Supraventricular extrasystoles | Cardiac disorders | Placebo + Fluoxetine | 1 | 87 | 1 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olanzapine + Fluoxetine | ||
| Total, all-cause mortality | Placebo + Fluoxetine | ||
| Total, other adverse events | Olanzapine + Fluoxetine | 55 | 88 |
| Total, other adverse events | Placebo + Fluoxetine | 45 | 87 |
| Total, serious adverse events | Olanzapine + Fluoxetine | 1 | 88 |
| Total, serious adverse events | Placebo + Fluoxetine | 1 | 87 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Olanzapine + Fluoxetine vs Placebo + Fluoxetine: 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/NCT01687478
GET https://conductscience.org/api/trials/v1/NCT01687478/results?page=2