Trial · NCT00612313

Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse

NCT00612313, Not applicable, Completed, University of Texas Southwestern Medical Center; results first posted 2014-12-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse. Trials, record NCT00612313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00612313

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse
NCT number: NCT00612313
Status: Completed
Phases: Not applicable
Enrollment: 144 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Depression
Interventions: Fluoxetine, Relapse prevention cognitive behavioral therapy (CBT)
First posted: 2008-02-11
Last updated: 2016-01-07
Results first posted: 2014-12-17
Limitations and caveats: * Primary outcomes based on data through 30 weeks.~* Participants were not blinded to treatment assignment.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Remission	30 weeks	Remission is defined as CDRS-R \<=28. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.
Primary	Relapse	Measured at Weeks 12, 18, 24, and 30	Relapse was defined as: 1\) CDRS-R score \>=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R\<40, but with a 2 week history of significant clinical deterioration.
Primary	Remission	Measured at Weeks 12, 18, 24, and 30	Remission is defined as CDRS-R \<=28.
Secondary	K-Life (Time Well)	30 weeks	K-Life interview was conducted at Weeks 6, 12, 18, 24, and 30, with ratings for depressive illness for each week throughout the study. Ratings definitions: 1=Normal, no residual symptoms; 2=Presence of 1 or more symptosm in no more than mild degree; 3=Considerably less psychopathology than full criteria, but still obvious evidence of disorder with no more than moderate impairment; 4=Does not meet full criteria, but has major symptoms or impairment from the disorder; 5=Meets full criteria, but no extreme impairment; 6=Meets full criteria, and either has prominent psychotic symptoms or extreme impairment. Time well is defined as each week the depression rating was a 1 or 2. Percent time well was defined as each week the depression rating was a 1 or 2 divided by the total number of weeks in the study. Statistic: anova
Secondary	Remission	Weeks 52 and 78	Remission is defined as CDRS-R \<=28 (up through week 30) or at least 8 consecutive weeks of a K-Life rating of 1 or 2. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.
Secondary	Relapse	Weeks 52 and 78	Up through week 30, relapse was defined as: 1\) CDRS-R score \>=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R\<40, but with a 2 week history of significant clinical deterioration. From week 31-78, relapse was assessed using the K-Life. Relapse was defined as at least 2 weeks of a K-Life rating of 5 or 6; participants may also be identified as relapsing with a K-Life rating of 4 if the rating was for several weeks and not strictly related to stressful life events.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Remission	30 weeks		weeks	MEAN
PRIMARY	Relapse	Measured at Weeks 12, 18, 24, and 30	Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.	probability of relapse (%)	NUMBER
SECONDARY	K-Life (Time Well)	30 weeks		Weeks spent well	MEAN
SECONDARY	Remission	Weeks 52 and 78		Probability of remission (%)	NUMBER
SECONDARY	Relapse	Weeks 52 and 78	Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.	Probability of Relapse (%)	NUMBER
PRIMARY	Remission	Measured at Weeks 12, 18, 24, and 30		probability of remitting (%)	NUMBER

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Remission	Continued Medication Alone		13.67	Standard Error 1.17	weeks
Time to Remission	Continued Medication Plus CBT		11.33	Standard Error 0.95	weeks
Relapse	Continued Medication Alone	Week 12	3		probability of relapse (%)
Relapse	Continued Medication Plus CBT	Week 12	1		probability of relapse (%)
Relapse	Continued Medication Alone	Week 18	10		probability of relapse (%)
Relapse	Continued Medication Plus CBT	Week 18	3.5		probability of relapse (%)
Relapse	Continued Medication Alone	Week 24	20.5		probability of relapse (%)
Relapse	Continued Medication Plus CBT	Week 24	7		probability of relapse (%)
Relapse	Continued Medication Alone	Week 30	26.5		probability of relapse (%)
Relapse	Continued Medication Plus CBT	Week 30	9		probability of relapse (%)

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Continued Medication Alone	69
Overall Study	STARTED	Continued Medication Plus CBT	75
Overall Study	COMPLETED	Continued Medication Alone	52
Overall Study	COMPLETED	Continued Medication Plus CBT	62
Overall Study	NOT COMPLETED	Continued Medication Alone	17
Overall Study	NOT COMPLETED	Continued Medication Plus CBT	13

Source ClinicalTrials.gov

Adverse events10

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
serious	Hospitalization for Suicide Attempt	Psychiatric disorders	Continued Medication Alone	1	69	1
serious	Hospitalization for Suicide Attempt	Psychiatric disorders	Continued Medication Plus CBT	0	75	0
serious	Hospitalization for Suicidal Ideation	Psychiatric disorders	Continued Medication Alone	3	69	3
serious	Hospitalization for Suicidal Ideation	Psychiatric disorders	Continued Medication Plus CBT	5	75	5
serious	Hospitalization for Agitation	Psychiatric disorders	Continued Medication Alone	1	69	1
serious	Hospitalization for Agitation	Psychiatric disorders	Continued Medication Plus CBT	0	75	0
serious	Hospitalization for medical conditions	General disorders	Continued Medication Alone	2	69	2
serious	Hospitalization for medical conditions	General disorders	Continued Medication Plus CBT	3	75	5
serious	Suicidal behavior that did not result in hospitalization	Psychiatric disorders	Continued Medication Alone	0	69	0
serious	Suicidal behavior that did not result in hospitalization	Psychiatric disorders	Continued Medication Plus CBT	1	75	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Continued Medication Alone
Total, all-cause mortality	Continued Medication Plus CBT
Total, other adverse events	Continued Medication Alone	0	69
Total, other adverse events	Continued Medication Plus CBT	0	75
Total, serious adverse events	Continued Medication Alone	7	69
Total, serious adverse events	Continued Medication Plus CBT	9	75

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24360599	DERIVED	PubMed
24935082	RESULT	PubMed
26598474	DERIVED	PubMed
40520979	DERIVED	PubMed

Grants1

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
R01MH039188	Pediatric MDD: Sequential Treatment with Fluoxetine and Relapse Prevention CBT	EMSLIE, GRAHAM J.; KENNARD, BETH D	UT SOUTHWESTERN MEDICAL CENTER	NATIONAL INSTITUTE OF MENTAL HEALTH	1986 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Continued Medication Alone vs Continued Medication Plus CBT: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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