Trial · NCT00958568
A Study in Relapse Prevention of Treatment-Resistant Depression
NCT00958568, Phase 3, Completed, Eli Lilly and Company; results first posted 2014-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Relapse Prevention of Treatment-Resistant Depression. Trials, record NCT00958568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00958568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Relapse Prevention of Treatment-Resistant Depression
- NCT number
- NCT00958568
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 892 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Treatment Resistant Depression
- Interventions
- Olanzapine and Fluoxetine combination (OFC), Fluoxetine
- First posted
- 2009-08-13
- Last updated
- 2014-04-01
- Results first posted
- 2014-04-01
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Relapse by Any Criteria | Randomization (Week 20) to Week 47 | Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation. |
| Secondary | Percentage of Participants Who Relapse by Any Criteria | Randomization (Week 20) to Week 47 | Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S 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 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. |
| Secondary | Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score | Randomization (Week 20) to Week 47 | Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S 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 (the most extremely ill). |
| Secondary | Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality | Randomization (Week 20) to Week 47 | |
| Secondary | Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality | Randomization (Week 20) to Week 47 | Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. |
| Secondary | Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score | Randomization (Week 20) to Week 47 | Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S 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 (the most extremely ill). Those who did not relapse were "censored" at their last observation. |
| Secondary | Time to Relapse as Measured by Hospitalization for Depression or Suicidality | Randomization (Week 20) to Week 47 | Those who did not relapse were "censored" at their last observation. |
| Secondary | Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality | Randomization (Week 20) to Week 47 | Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation. |
| Secondary | Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase | Week 0 to Week 8 | A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S 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). |
| Secondary | Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase | Week 8 to Week 20 | A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S 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). |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse by Any Criteria | Randomization (Week 20) to Week 47 | All randomized participants are included in the time to event analyses. The numbers of participants censored are 186 and 152 for OFC and Flu groups, respectively. | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Relapse by Any Criteria | Randomization (Week 20) to Week 47 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score | Randomization (Week 20) to Week 47 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality | Randomization (Week 20) to Week 47 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality | Randomization (Week 20) to Week 47 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score | Randomization (Week 20) to Week 47 | All randomized participants are included in the time to event analyses. The numbers of participants censored are 190 and 160 for OFC and Flu groups, respectively. | days | MEDIAN |
| SECONDARY | Time to Relapse as Measured by Hospitalization for Depression or Suicidality | Randomization (Week 20) to Week 47 | All randomized participants are included in the time to event analyses. The numbers of participants censored are 217 and 220 for OFC and Flu groups, respectively. | days | MEDIAN |
| SECONDARY | Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality | Randomization (Week 20) to Week 47 | All randomized participants are included in the time to event analyses. The numbers of participants censored are 197 and 160 for OFC and Flu groups, respectively. | days | MEDIAN |
| SECONDARY | Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase | Week 0 to Week 8 | All participants who entered open-label acute treatment phase (SPII). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase | Week 8 to Week 20 | All participants who entered open-label stabilization treatment phase (SPIII). | percentage of participants | NUMBER |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group103
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Relapse by Any Criteria | OFC (SPIV) | NA | Full Range 10.0 | days | |
| Time to Relapse by Any Criteria | Flu (SPIV) | NA | Full Range 5.9 | days | |
| Percentage of Participants Who Relapse by Any Criteria | OFC (SPIV) | 15.8 | percentage of participants | ||
| Percentage of Participants Who Relapse by Any Criteria | Flu (SPIV) | 31.8 | percentage of participants | ||
| Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score | OFC (SPIV) | 14.0 | percentage of participants | ||
| Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score | Flu (SPIV) | 28.3 | percentage of participants | ||
| Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality | OFC (SPIV) | 1.8 | percentage of participants | ||
| Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality | Flu (SPIV) | 1.3 | percentage of participants | ||
| Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality | OFC (SPIV) | 10.9 | percentage of participants | ||
| Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality | Flu (SPIV) | 28.3 | percentage of participants |
1 to 10 of 103Source ClinicalTrials.gov
See all 103 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| SPII (Wk 0-8, Acute Open-label) | STARTED | OFC (SPII ) | 892 | |
| SPII (Wk 0-8, Acute Open-label) | STARTED | OFC (SPIII) | 0 | |
| SPII (Wk 0-8, Acute Open-label) | STARTED | OFC (SPIV) | 0 | |
| SPII (Wk 0-8, Acute Open-label) | STARTED | Flu (SPIV) | 0 | |
| SPII (Wk 0-8, Acute Open-label) | COMPLETED | OFC (SPII ) | 655 | |
| SPII (Wk 0-8, Acute Open-label) | COMPLETED | OFC (SPIII) | 0 | |
| SPII (Wk 0-8, Acute Open-label) | COMPLETED | OFC (SPIV) | 0 | |
| SPII (Wk 0-8, Acute Open-label) | COMPLETED | Flu (SPIV) | 0 | |
| SPII (Wk 0-8, Acute Open-label) | NOT COMPLETED | OFC (SPII ) | 237 | |
| SPII (Wk 0-8, Acute Open-label) | NOT COMPLETED | OFC (SPIII) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events308
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 | Constipation | Gastrointestinal disorders | OFC (SPII) | 24 | 892 | 25 |
| other | Constipation | Gastrointestinal disorders | OFC (SPIII) | 3 | 655 | 3 |
| other | Constipation | Gastrointestinal disorders | OFC (SPIV) | 0 | 221 | 0 |
| other | Constipation | Gastrointestinal disorders | Flu (SPIV) | 0 | 223 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | OFC (SPII) | 20 | 892 | 20 |
| other | Diarrhoea | Gastrointestinal disorders | OFC (SPIII) | 5 | 655 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | OFC (SPIV) | 5 | 221 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Flu (SPIV) | 6 | 223 | 7 |
| other | Dry mouth | Gastrointestinal disorders | OFC (SPII) | 125 | 892 | 129 |
| other | Dry mouth | Gastrointestinal disorders | OFC (SPIII) | 8 | 655 | 8 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OFC (SPII) | ||
| Total, all-cause mortality | OFC (SPIII) | ||
| Total, all-cause mortality | OFC (SPIV) | ||
| Total, all-cause mortality | Flu (SPIV) | ||
| Total, other adverse events | OFC (SPII) | 606 | 892 |
| Total, other adverse events | OFC (SPIII) | 348 | 655 |
| Total, other adverse events | OFC (SPIV) | 100 | 221 |
| Total, other adverse events | Flu (SPIV) | 105 | 223 |
| Total, serious adverse events | OFC (SPII) | 13 | 892 |
| Total, serious adverse events | OFC (SPIII) | 9 | 655 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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.
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