An interventional study of Fluoxetine and Relapse prevention cognitive behavioral therapy (CBT) in Depression, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-01-07.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
This study will compare the effectiveness of fluoxetine alone with the effectiveness of fluoxetine with cognitive behavioral therapy in increasing recovery and preventing relapse in youth with major depressive disorder.
Major depressive disorder (MDD) is a serious psychiatric disorder that affects approximately 1 out of every 12 to 15 children and adolescents. Depression can cause problems with school, family, and friends, and if left untreated, these difficulties can persist into adulthood. Treatments using antidepressants and forms of psychotherapy have been shown to be effective in reducing symptoms of depression. However, many youth experience a return of depressive symptoms within 1 to 2 years of remission. Recent studies have shown that adding cognitive behavioral therapy (CBT), a form of psychotherapy that focuses on behavioral modification, to initial antidepressant treatment may increase remission and reduce relapse rates. This study will compare the effectiveness of fluoxetine alone versus fluoxetine plus added CBT in increasing recovery and preventing relapse in youth with MDD.
Participation in this study will last 78 weeks. Potential participants will undergo initial screening, which will include interviews and questionnaires about mood, behavior, and medical history; vital sign measurements; a meeting with a psychiatrist; and lab draws and/or urine drug or pregnancy tests if indicated by the psychiatrist. All eligible participants will then begin 6 weeks of treatment with fluoxetine. During this 6-week period, participants will attend weekly study visits, which will include vital sign measurements, questionnaires on symptoms and mood, and medication dosage adjustments. At Week 6, participants will be evaluated by an independent evaluator who will determine whether their depression has significantly improved. Participants who have not improved with fluoxetine will end their study participation and will be provided with recommendations for other treatment options.
All participants who have shown significant improvement will continue to receive fluoxetine for another 24 weeks, for a total of 30 weeks of treatment. Half of these participants will be randomly assigned to additionally receive CBT for the remaining 24 weeks. All participants will attend study visits that will occur every other week for 3 months and then monthly for 3 months. These visits will last 20 to 30 minutes and will include vital sign measurements and questions about mood and behavior. Participants receiving CBT will also attend 10 to 12 CBT sessions, which will last 50 minutes each and will occur weekly for the first 4 weeks, every other week for 1.5 months, and monthly for the last 3 months. The CBT sessions will involve both individual child and parent-child sessions, which will focus on modifying depressive thoughts, feelings, and behaviors. Participants will undergo repeat evaluations with the independent evaluator at Weeks 12, 18, 24, 30, 52, and 78.
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Exclusion Criteria:
Participants will receive antidepressant treatment with fluoxetine for 30 weeks
Drug: Fluoxetine
Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Drug: Fluoxetine · Behavioral: Relapse prevention cognitive behavioral therapy (CBT)
Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
Also known as: Prozac
After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms.
Also known as: CBT
Time to Remission
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.
Time frame: 30 weeks
Relapse
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.
Time frame: Measured at Weeks 12, 18, 24, and 30
Remission
Remission is defined as CDRS-R \<=28.
Time frame: Measured at Weeks 12, 18, 24, and 30
K-Life (Time Well)
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
Time frame: 30 weeks
Remission
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.
Time frame: Weeks 52 and 78
Relapse
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.
Time frame: Weeks 52 and 78
200 participants began acute phase open-label treatment with fluoxetine. Of these, 144 entered the randomized control study. Results data presented are for 144 participants randomized.
| Milestone | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| Started | 69 | 75 |
| Completed | 52 | 62 |
| Not completed | 17 | 13 |
| Withdrew: Withdrawal by subject | 6 | 9 |
| Withdrew: Lost to follow-up | 11 | 4 |
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.
| weeks | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| Time to Remission | 13.67 ± 1.17 | 11.33 ± 0.95 |
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.
| probability of relapse (%) | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| Week 12 | 3 | 1 |
| Week 18 | 10 | 3.5 |
| Week 24 | 20.5 | 7 |
| Week 30 | 26.5 | 9 |
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
| Weeks spent well | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| K-Life (Time Well) | 12.8 ± 9.5 | 16.0 ± 9.1 |
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.
| Probability of remission (%) | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| Week 52 | 89 | 94 |
| Week 78 | 92 | 96 |
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.
| Probability of Relapse (%) | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| Week 52 | 49 | 27 |
| Week 78 | 62 | 36 |
Remission is defined as CDRS-R \<=28.
| probability of remitting (%) | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| Week 12 | 59 | 68 |
| Week 18 | 71 | 79 |
| Week 24 | 80 | 86 |
| Week 30 | 84 | 90 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continued Medication Alone | — | 7/69 (10.1%) | 0/69 (0%) |
| Continued Medication Plus CBT | — | 9/75 (12%) | 0/75 (0%) |
| Event | Continued Medication Alone | Continued Medication Plus CBT |
|---|---|---|
| Hospitalization for Suicidal IdeationPsychiatric disorders | 3/69 | 5/75 |
| Hospitalization for medical conditionsGeneral disorders | 2/69 | 3/75 |
| Hospitalization for Suicide AttemptPsychiatric disorders | 1/69 | 0/75 |
| Hospitalization for AgitationPsychiatric disorders | 1/69 | 0/75 |
| Suicidal behavior that did not result in hospitalizationPsychiatric disorders | 0/69 | 1/75 |
| Age, Continuous(Years) | Continued Medication Alone | Continued Medication Plus CBT | Total |
|---|---|---|---|
| Mean | 14.2 ± 2.4 | 13.5 ± 2.7 | 13.8 ± 2.6 |
| Sex: Female, Male(Participants) | Continued Medication Alone | Continued Medication Plus CBT | Total |
|---|---|---|---|
| Female | 39 | 38 | 77 |
| Male | 30 | 37 | 67 |
| Ethnicity (NIH/OMB)(Participants) | Continued Medication Alone | Continued Medication Plus CBT | Total |
|---|---|---|---|
| Hispanic or Latino | 20 | 23 | 43 |
| Not Hispanic or Latino | 49 | 52 | 101 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Continued Medication Alone | Continued Medication Plus CBT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 8 | 15 |
| White | 54 | 64 | 118 |
| More than one race | 7 | 2 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Continued Medication Alone | Continued Medication Plus CBT | Total |
|---|---|---|---|
| United States | 69 | 75 | 144 |
| Baseline CDRS-R(units on a scale) | Continued Medication Alone | Continued Medication Plus CBT | Total |
|---|---|---|---|
| Mean | 59.2 ± 7.0 | 56.8 ± 7.1 | 58.0 ± 7.2 |
| Baseline CGI Severity(units on a scale) | Continued Medication Alone | Continued Medication Plus CBT | Total |
|---|---|---|---|
| Mean | 5.3 ± 0.69 | 5.1 ± 0.7 | 5.2 ± 0.7 |
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University of Texas Southwestern Medical Center