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Major Depressive DisorderNCT01740726

Comparison of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Depression

A study testing Behavioral Activation and Fluoxetine in people with Major Depressive Disorder, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study focuses on treating adolescents with depression. The study has two main purposes. The first is to compare a new form of therapy for depression called Behavioral Activation (BA) to the antidepressant medication fluoxetine. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Behavioral Activation and Fluoxetine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Jan 2013to Mar 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male and female adolescents ages 13-17
  • Current diagnosis of Major Depressive Disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL), Children's Depression Rating Scale (CDRS-R) raw score > 45 (T-score > 65) at baseline
  • Estimated full scale IQ > 80 as determined by the Wechsler Intelligence Scale for Children (WISC)
  • Able to receive outpatient care
  • Willing to discontinue other psychosocial treatments
  • Not taking psychotropic medications in the one month prior to consent, with the exception of psychostimulant medication prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD)

Who cannot join

  • Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis not otherwise specified
  • Current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, obsessive-compulsive disorder, or autism-spectrum disorders
  • Taking psychotropic medications prior to entry
  • Estimated IQ < 80
  • Alcohol/drug dependence or abuse within the last 3 months
  • Potential/confirmed neurological disorder or epilepsy
Show all 11Show fewer
  • Claustrophobia
  • Presence of a medical condition that precludes fMRI
  • Endorsement of imminent and serious suicidality
  • Medical conditions for which treatment with fluoxetine is contraindicated or that take precedence over the presence of major depressive disorder (MDD)
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Emory Executive Park

    Atlanta, Georgia, 30329

Other trials in United States

About this study

Official title: Randomized Trial of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Major Depression

This study focuses on treating adolescents with depression. The study has two main purposes. The first is to compare a new form of therapy for depression called Behavioral Activation (BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more involved in activities they find enjoyable, which can reduce symptoms of depression. Research shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However, unlike previous research, this study examines how well the two treatment options work in comparison to each other. Participants in the study are randomized to receive treatment with either BA or fluoxetine for 18 weeks.

The second aim of the study is to examine the brain functions of adolescents in both treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans before and after treatment. The data from these scans will be used to compare the brains of participants in the BA condition with those in the fluoxetine condition. Also, the scans may show possible differences between participants' brains before and after treatment. These data may help scientists determine the ideal form of depression treatment for different types of people.

Read the detailed description

Depression is a serious diagnosis that can have severe consequences; it is not just experiencing "the blues" or having sad feelings that most people get from time to time. People who are diagnosed with depression have overwhelming feelings of sadness that are present for at least two weeks. In addition, they also experience symptoms such as changes in their appetite or sleep patterns, feelings of guilt or worthlessness, lack of energy or motivation, and even thoughts of suicide. People with depression have difficulty functioning in many areas of their lives, including at work, at school, and in social relationships. Those who have this diagnosis often need medication, therapy, or a combination of both to relieve their symptoms and regain their usual functioning.

This study investigates whether a type of psychotherapy called Behavioral Activation (BA) is as effective as antidepressant medication in the treatment of adolescents diagnosed with depression. In this study, BA is compared to fluoxetine, which is known to help treat depressive symptoms in this population. BA has been shown to be efficacious in reducing depression in adolescents, but it is not yet known how it compares to another leading treatment for depression in this age group. Thus, this study's primary goal is to see how BA compares to fluoxetine.

This study also examines brain activity as it relates to depression and treatment. The study includes functional Magnetic Resonance Imaging (fMRI) scans of participants in both conditions before and after they undergo treatment. Participants play a game in the scanner called the Monetary Incentive Delay (MID) task, and they have the opportunity to win money (reward) or to avoid losing money (loss). After they play the MID game, the scan images show certain brain regions that are activated in reward and loss situations. This study looks at how these brain regions relate to treatment response, especially because the goal of BA is to help people enjoy rewards more. The study also compares brain activity between the two treatment groups, as well as changes in brain activity from pre- to post-treatment. This part of the study should provide information about which kinds of people respond to which kinds of treatment.

Behavioral activation is a new therapy that has been shown to successfully treat depressed adults and adolescents. BA is a type of therapy that helps depressed people get involved in activities that they find to be enjoying and rewarding. The developers of this therapy believe that people are depressed because they are not experiencing rewarding and positive events in their lives very often. For example, when people become depressed, they usually become isolated from others. They also stop doing the things they used to enjoy, or they do them far less often. As a result, they have fewer experiences that make them feel a sense of accomplishment and happiness, and their depression becomes more severe. The worse the symptoms get, the less they engage in rewarding activities. The developers of BA have established a therapy program that helps the patient choose and participate in activities that are rewarding. The therapist acts as a coach, monitoring progress and giving feedback about these activities and the relationship between this activation and mood. This type of therapy is not just designed to get depressed people to do more; rather, time is spent choosing and evaluating specific activities that are particularly rewarding for the client and evaluating the outcome of these activities. Although BA is a novel intervention, early evidence shows that BA is effective with regard to alleviating symptoms of depression. In addition, the results of these studies show that it works in a relatively short amount of time (approximately four months).

Because so little is known about effective psychosocial treatments for depressed adolescents, and because of the risks associated with treating adolescents with medications, it is important to work on developing and supporting new treatments for this at-risk population. The aim of this pilot study is to generate knowledge for both the scientific community and for clinicians by gaining new insight into what works for depressed teens. To accomplish these goals, this study will treat 20 adolescents who meet criteria for Major Depressive Disorder with 18 weeks of therapy or medication. Ten adolescents will be assigned to the BA condition, and 10 will be assigned to the fluoxetine condition. Those in the medication condition will visit with their psychiatrist regularly but will not receive psychotherapy. Those who receive BA will receive between 18 and 20 sessions of therapy.

It is important to note that people are experiencing first episodes of depression at younger and younger ages; hence, rates of depression are rising in younger age groups. Also, suicide is the third leading cause of death among adolescents, and depression is associated with increased thoughts of suicide and suicide attempts. Depressed children and adolescents are more likely to develop a host of other problems, such as substance abuse, and they are more likely to report experiencing stressful life events. For all these reasons, it is important that scientists work to develop therapies that relieve depression in this population. Studies such as this one can help advance knowledge about how best to treat this dangerous illness.

Being tested
Behavioral Activation, Fluoxetine
Keywords
Depression, Behavioral Activation, Fluoxetine, Prozac, Treatment, Therapy, Psychotherapy, Antidepressant, Intervention
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral ActivationBehavioural

    Also called Behavioral Activation Therapy, BA

    18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.

  • FluoxetineDrug

    Also called Prozac, Sarafem, Rapiflux, Selfemra

    Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.

Study groups in NCT01740726
Study groupRoleWhat they receive
Behavioral ActivationExperimentalNot described
Receives: Behavioral: Behavioral Activation
FluoxetineActive comparatorNot described
Receives: Drug: Fluoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)

    Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.

    Measured: Baseline, 42 weeks

  2. Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)

    Interview-based measure, completed with both the parent and child, that assesses depression severity.

    Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

Secondary outcomes (5)
  1. Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)

    Clinician's rating of symptom severity and improvement since baseline.

    Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

  2. Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)

    Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.

    Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

  3. Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)

    Measures anxiety symptom severity.

    Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

  4. Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)

    Assesses seriousness of suicidal intent.

    Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

  5. Change in Hope Based on Children's Hope Scale (CHS)

    Assesses self-perception of ability to set and work toward goals.

    Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: Lack of success with recruitment

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740726
Sponsor's protocol ID
IRB00061525
Other IDs
CAMP-61525
Status last verified
Mar 2015
First submitted
28 Nov 2012
Last updated
20 Dec 2017
Data monitoring committee
Yes

Publications

  • Ritschel, L. A., Ramirez, C. L., Jones, M., & Craighead, W. (2011). Behavioral activation for depressed teens: A pilot study. Cognitive And Behavioral Practice, 18(2), 281-299. doi:10.1016/j.cbpra.2010.07.002

  • Jacob M, Keeley ML, Ritschel L, Craighead WE. Behavioural activation for the treatment of low-income, African American adolescents with major depressive disorder: a case series. Clin Psychol Psychother. 2013 Jan-Feb;20(1):87-96. doi: 10.1002/cpp.774. Epub 2011 Aug 22.

    PubMed 21861272

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Activation and Fluoxetine in people with Major Depressive Disorder, run by Emory University 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Dec 2017. 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?

Yes. Results are posted in the registry (first posted 7 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II) (time frame: Baseline, 42 weeks). The study lists 2 primary outcomes in all. 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 NCT01740726, 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 20 Dec 2017.

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