Trial · NCT00118404
Cognitive Therapy for Recurrent Depression
NCT00118404, Phase 3, Completed, University of Texas Southwestern Medical Center; results first posted 2014-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cognitive Therapy for Recurrent Depression. Trials, record NCT00118404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118404
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cognitive Therapy for Recurrent Depression
- NCT number
- NCT00118404
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 523 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Depression
- Interventions
- Continuation phase cognitive therapy, Continuation phase fluoxetine, Continuation phase pill placebo, Acute phase cognitive therapy
- First posted
- 2005-07-11
- Last updated
- 2014-06-05
- Results first posted
- 2014-06-05
- Limitations and caveats
To our knowledge in 2014 this is of the largest, cognitive therapy responders who presented with recurrent MDD and were followed longitudinally~Proficient therapists;competency measured.~Generalizability is limited by design characteristics.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Depressive Relapse or MDD | Measured at month 8 | Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481) |
| Primary | Depressive Relapse/Recurrence or MDD | Measured at month 20 | Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481) |
| Primary | Depressive Relapse/Recurrence or MDD | Measured at month 32 | Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Depressive Relapse or MDD | Measured at month 8 | Intention to treat analysis | % patients who relapsed | NUMBER |
| PRIMARY | Depressive Relapse/Recurrence or MDD | Measured at month 20 | Intention to treat analysis | % patients who relapsed/recurred | NUMBER |
| PRIMARY | Depressive Relapse/Recurrence or MDD | Measured at month 32 | Intention to treat analysis | % patients who relapsed/recurred | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Depressive Relapse or MDD | Continuation Phase Fluoxetine | 18 | % patients who relapsed | ||
| Depressive Relapse or MDD | Continuation Phase Cognitive Therapy | 18.3 | % patients who relapsed | ||
| Depressive Relapse or MDD | Continuation Phase Pill Placebo | 32.7 | % patients who relapsed | ||
| Depressive Relapse/Recurrence or MDD | Continuation Phase Fluoxetine | 35.1 | % patients who relapsed/recurred | ||
| Depressive Relapse/Recurrence or MDD | Continuation Phase Cognitive Therapy | 35.0 | % patients who relapsed/recurred | ||
| Depressive Relapse/Recurrence or MDD | Continuation Phase Pill Placebo | 42.7 | % patients who relapsed/recurred | ||
| Depressive Relapse/Recurrence or MDD | Continuation Phase Fluoxetine | 41.1 | % patients who relapsed/recurred | ||
| Depressive Relapse/Recurrence or MDD | Continuation Phase Cognitive Therapy | 45.2 | % patients who relapsed/recurred | ||
| Depressive Relapse/Recurrence or MDD | Continuation Phase Pill Placebo | 56.3 | % patients who relapsed/recurred |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Continuation Phase Fluoxetine | 86 | |
| Overall Study | STARTED | Continuation Phase Cognitive Therapy | 86 | |
| Overall Study | STARTED | Continuation Phase Pill Placebo | 69 | |
| Overall Study | COMPLETED | Continuation Phase Fluoxetine | 62 | |
| Overall Study | COMPLETED | Continuation Phase Cognitive Therapy | 70 | |
| Overall Study | COMPLETED | Continuation Phase Pill Placebo | 49 | |
| Overall Study | NOT COMPLETED | Continuation Phase Fluoxetine | 24 | |
| Overall Study | NOT COMPLETED | Continuation Phase Cognitive Therapy | 16 | |
| Overall Study | NOT COMPLETED | Continuation Phase Pill Placebo | 20 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Continuation Phase Fluoxetine | ||
| Total, all-cause mortality | Continuation Phase Cognitive Therapy | ||
| Total, all-cause mortality | Continuation Phase Pill Placebo | ||
| Total, other adverse events | Continuation Phase Fluoxetine | 0 | 86 |
| Total, other adverse events | Continuation Phase Cognitive Therapy | 0 | 86 |
| Total, other adverse events | Continuation Phase Pill Placebo | 0 | 69 |
| Total, serious adverse events | Continuation Phase Fluoxetine | 0 | 86 |
| Total, serious adverse events | Continuation Phase Cognitive Therapy | 0 | 86 |
| Total, serious adverse events | Continuation Phase Pill Placebo | 0 | 69 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants4
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01MH058397 | Prophylactic Cognitive Therapy for Depression | JARRETT, ROBIN B | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE OF MENTAL HEALTH | 2000 to 2011 | NIH RePORTER |
| R01MH058356 | Prophylactic Cognitive Therapy for Depression | THASE, MICHAEL E | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF MENTAL HEALTH | 2000 to 2010 | NIH RePORTER |
| R01MH069619 | Are Cognitive Therapy's Antidepressant Effects Durable? | JARRETT, ROBIN B | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE OF MENTAL HEALTH | 2004 to 2009 | NIH RePORTER |
| R01MH069618 | Are Cognitive Therapy's Antidepressant Effects Durable? | FRIEDMAN, EDWARD S. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF MENTAL HEALTH | 2004 to 2008 | NIH RePORTER |
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/NCT00118404
GET https://conductscience.org/api/trials/v1/NCT00118404/registered