DepressionNCT00158301
Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents
A study testing Cognitive behavioral therapy (CBT) and Drug therapy in people with Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive behavioral therapy (CBT) and Drug therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
- Clinical Global Impression severity score of 4 or greater
- Children's Depression Rating Scale score of 40 or greater
- Currently attending school
- Willing and able to use acceptable methods of contraception, if applicable
- In good general health
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- History of psychotic disorders
- Alcohol or substance abuse or dependence within 6 months prior to study entry
- History of anorexia nervosa or bulimia
- Chronic medical illness requiring regular medication
- Current use of medication with psychotropic effects
- First-degree relatives (e.g., mother, father, sister, brother) with bipolar I disorder
Show all 10Show fewer
- At risk for suicide
- Failure of a previous adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
- IQ less than 80
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
Official title: Continuation Phase CBT for Youth With MDD
This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.
Read the detailed description
Depression is a chronic and episodic condition that may have devastating effects on social and emotional functioning, particularly in the pediatric population. While approximately 90% of children eventually recover from an episode of depression, up to 40% of those children relapse within 1 to 2 years. Data indicate that cognitive behavioral therapy (CBT) delivered after depressive symptoms subside can significantly reduce depression relapses in adults. However, there are no comparable studies in children or adolescents. This study will determine whether CBT is effective in reducing a relapse of depressive episodes in children and adolescents with major depression.
This study comprises two phases. In Phase 1, all participants will receive drug treatment for 12 weeks. Participants who respond to the treatment will complete the study after 12 weeks. Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2. In Phase 2, participants will be randomly assigned to either continue drug therapy alone or to receive drug therapy plus CBT for 6 months. The CBT will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms. Self-report scales will be used to assess the depressive symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the study.
- Conditions
- Depression
- Being tested
- Cognitive behavioral therapy (CBT), Drug therapy
- Keywords
- Child, Adolescent, CBT, Drug Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
CBT sessions will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms.
Drug therapyDrug
Also called fluoxetine
All participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response Receives: Behavioral: Cognitive behavioral therapy (CBT); Drug: Drug therapy |
| 2 | Active comparator | Continuation phase drug therapy only for 6 more months following acute treatment response Receives: Drug: Drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of depressive symptoms
Measured: Measured at Months 3 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionNov 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Beth D. Kennard, PsyD, Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158301
- Sponsor's protocol ID
- R34MH072737
- Other IDs
- R34MH072737, DSIR 84-CTS
- Status last verified
- Nov 2013
- First submitted
- 7 Sep 2005
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nakonezny PA, Hughes CW, Mayes TL, Sternweis-Yang KH, Kennard BD, Byerly MJ, Emslie GJ. A comparison of various methods of measuring antidepressant medication adherence among children and adolescents with major depressive disorder in a 12-week open trial of fluoxetine. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.
PubMed 20973714Kennard BD, Emslie GJ, Mayes TL, Nightingale-Teresi J, Nakonezny PA, Hughes JL, Jones JM, Tao R, Stewart SM, Jarrett RB. Cognitive-behavioral therapy to prevent relapse in pediatric responders to pharmacotherapy for major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1395-404. doi: 10.1097/CHI.0b013e31818914a1.
PubMed 18978634
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation Phase CBT for Youth With MDD
- ClinicalTrials.gov ID
- NCT00158301
- Acronym / sponsor ID
- R34MH072737
- Conditions
- Depression
- Keywords
- Child, Adolescent, CBT, Drug Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.
Detailed description
Depression is a chronic and episodic condition that may have devastating effects on social and emotional functioning, particularly in the pediatric population. While approximately 90% of children eventually recover from an episode of depression, up to 40% of those children relapse within 1 to 2 years. Data indicate that cognitive behavioral therapy (CBT) delivered after depressive symptoms subside can significantly reduce depression relapses in adults. However, there are no comparable studies in children or adolescents. This study will determine whether CBT is effective in reducing a relapse of depressive episodes in children and adolescents with major depression.
This study comprises two phases. In Phase 1, all participants will receive drug treatment for 12 weeks. Participants who respond to the treatment will complete the study after 12 weeks. Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2. In Phase 2, participants will be randomly assigned to either continue drug therapy alone or to receive drug therapy plus CBT for 6 months. The CBT will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms. Self-report scales will be used to assess the depressive symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive behavioral therapy (CBT), Drug: Drug therapyContinuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response |
| 2 | Active comparator | Drug: Drug therapyContinuation phase drug therapy only for 6 more months following acute treatment response |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
- Clinical Global Impression severity score of 4 or greater
- Children's Depression Rating Scale score of 40 or greater
- Currently attending school
- Willing and able to use acceptable methods of contraception, if applicable
Key exclusion criteria (10 listed)
- History of psychotic disorders
- Alcohol or substance abuse or dependence within 6 months prior to study entry
- History of anorexia nervosa or bulimia
- Chronic medical illness requiring regular medication
- Current use of medication with psychotropic effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy (CBT)CBT sessions will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms. | Behavioural | 1 |
| Drug therapyAlso: fluoxetineAll participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms). | Drug | 1, 2 |
Primary outcome
Relapse of depressive symptoms
Time frame: Measured at Months 3 and 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 20973714Nakonezny PA, Hughes CW, Mayes TL, Sternweis-Yang KH, Kennard BD, Byerly MJ, Emslie GJ. A comparison of various methods of measuring antidepressant medication adherence among children and adolescents with major depressive disorder in a 12-week open trial of fluoxetine. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.
- Derived from this study: PubMed 18978634Kennard BD, Emslie GJ, Mayes TL, Nightingale-Teresi J, Nakonezny PA, Hughes JL, Jones JM, Tao R, Stewart SM, Jarrett RB. Cognitive-behavioral therapy to prevent relapse in pediatric responders to pharmacotherapy for major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1395-404. doi: 10.1097/CHI.0b013e31818914a1.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth D. Kennard, PsyD principal investigator
University of Texas, Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) and Drug therapy in people with Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse of depressive symptoms (time frame: Measured at Months 3 and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00158301, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.