What Is TADS?
The Treatment for Adolescents with Depression Study, TADS, is a research study of treatments for Major Depressive Disorder in teenagers. TADS will compare the short- and longer-term effectiveness of medication and psychotherapy for depression, also known as Major Depressive Disorder, in teenagers. For teens treated in TADS, the trial is designed to provide best-practice practical care for depression. It is our hope that the overall study results will improve the future care of adolescents with depression.
What Are The Symptoms Of Depression?
Not everyone with depression has exactly the same symptoms. However, everyone has some combination of the following symptoms:
- Mood changes may cause a teenager to be persistently sad, ‘depressed,’ irritable or cranky, to be easily angered, to cry frequently, or to have difficulty getting along with family members. Often irritable teenagers don’t think of themselves as ‘depressed’ because they do not feel sad.
- Loss of interest in things that used to excite them, such as hobbies, sports, or social activities.
- Loss of enjoyment even when they are active and still seem interested. For example, a teenager with depression may feel bored most of the time, spend a lot more time than usual alone in own room, and avoid going out with friends.
- Sleep changes, such as difficulty falling asleep or staying asleep. The teenager may go to bed at the usual time but stay awake for an hour or more, unable to relax and drift into sleep. He or she may get up several times during the night, unable to sleep soundly through the night. Or awaken very early in the morning (for example, 2 or more hours before needed/planned to get up) but not feeling rested. They may sleep much more than normal, going to bed early and having a hard time getting up in the morning, then coming home in the afternoon and taking naps. Or reverse their whole sleep cycle so that they are up all-night and asleep much of the day.
- Appetite changes. It can shrink, so that they are not as hungry as usual; or it can expand, so that they want to eat all the time.
- Weight change, including gaining or losing a lot of weight.
- Changes in energy levels. He or she may feel tired a lot of the time or seem to have lost ‘pep.’ Parents and friends may see the adolescent as moving more slowly than normal, or conversations may seem strained because it seems to take a long time for the teenager to respond to questions or comments. The opposite can also happen: the teenager may seem all ‘charged up’ or agitated. He or she may pace back and forth, go out for long walks, or seem unusually restless.
- School Difficulties. A teenager with depression may have a hard time concentrating in school. He or she may forget assignments or appointments in a way that was not typical of them before they became depressed. Or they may find it hard to keep their minds on things they are reading or doing. Grades also may decline.
- Personal critiques. Adolescents with depression may be excessively critical of themselves. They may feel they can’t do anything right, feel worthless, or even feel that they are to blame for things that are not really their fault.
- Self-harm, including thoughts and/or conversations about hurting themselves, or about what it would be like if they were dead. They may develop a suicide plan or attempt to hurt or kill themselves.
How Common Is Major Depression?
Studies in the United States show that, at any particular time, 2 to 3% of teenagers have moderately severe to severe Major Depression. This means that in a high school of 1000 adolescents, between 20 and 30 would be likely to be in the midst of a significant Major Depressive episode on any given day. It occurs both in boys and in girls.
When teenagers are asked about depression over the course of their whole life, about 18% report having had one or more episodes of Major Depression. A substantial number but by no means all depressed teenagers have suicidal thoughts, and without effective treatment some will eventually commit suicide. As this demonstrates, Major Depression is one of the most common disorders of adolescents.
Who Can Be In TADS?
We are recruiting teenagers, between 12-17 years of age, who are currently experiencing symptoms of depression. Participation of at least one parent is required.
What Does it Cost to Participate?
There is no charge for the medical evaluation, study medication, and/or treatment sessions provided by the study clinical team.
How Long Will the Study Last?
The treatment period may last up to 9 months, depending on how well the teen is doing. After the treatment period, there is a 1-year assessment period in which the long-term benefits of the treatments are evaluated. Hence, each teen may be asked to participate for as long as 21 months.
What Treatments Will Be Used?
The treatments used in this study have been proven effective with many adolescents and adults. The different treatments are:
- Fluoxetine (Prozac®) – medication alone
- Placebo (sugar pill) – medication alone
- Cognitive Behavior Therapy (CBT) – talking with a therapist
- Combination of both medication and CBT
Prozac has been approved by the Food and Drug Administration for use in the treatment of adult depression. The placebo condition helps us determine to what extent the active treatments improve adolescent depression relative to an inactive treatment. Cognitive behavioral therapy, which is used to treat depression, teaches the teenager and family new skills to cope with and then relieve the teenager’s depression. The combination condition allows us to evaluate the relative benefits of combining the two treatments when treating depressed teenagers.
How Often Will Clinic Visits be Needed?
The study involves a number of visits to the clinic. Some are treatment sessions; others are assessment visits. The total number of visits depends on the treatment assigned and how well the teenager is responding to treatment. Some clinic visits will take only 30 minutes, while other visits will require several hours to complete. During the first 3 months of treatment, patients who are receiving CBT will visit the clinic 12-14 times, about once per week. Patients who receive only pills will visit the clinic 6-9 times. Parents also attend some of the visits with their teen.
There are 2-3 screening visits to determine whether your teenager is eligible for the study. During these visits, the teen receives a thorough medical evaluation.
What Will Happen During the Treatment Phase of the Study?
The 9-month treatment phase is conducted in stages.
- Stage I lasts 12 weeks and includes 6-14 visits to the clinic.
In this stage teens are randomized to one of 4 treatments—active medication alone (Prozac®), placebo alone, CBT alone, or active medication + CBT.
If the teen was assigned to Prozac® alone or placebo alone, the family and doctors are told that the teen will receive “pills only”. At the end of this 12-week stage the teen, family and doctors are told which medication was taken by the teen. If depression does not improve during the first 12 weeks for those teens who were taking the placebo, or it returns within three months, a choice of any one of the other three treatments — active medication, psychotherapy, or both is offered free of charge.
- Stage II takes 6 weeks and involves 2-6 visits to the clinic.
Teenagers who respond well continue with their original treatment during Stages II and III. During these stages there will only be three treatment groups – Prozac® alone, CBT alone, and Prozac® + CBT.
- Stage III lasts 18 weeks and includes 3 clinic visits.
If your teenager’s depression worsens or does not improve, the doctor will talk with the family about other treatment options.
What Does a Parent(s) or Guardian Have to Do?
The study requires that at least one parent complete various questionnaires and interviews. In addition, the parent will be asked to participate in some of the treatment sessions. If the teenager does not live with one or both parents, we ask that an adult with whom the teenager lives most of the time take part in the study.
What Happens During the Follow-up Period?
During the one year follow-up period, participants will come to the clinic four times at 3, 6, 9, and 12 months following the end of the treatment period. These visits are called “assessments” and will consist of interviews and completing questionnaires similar to those already done at the beginning of the study.
Because the study does not provide treatment during the follow-up period, the TADS doctors will meet with the family when needed or requested to discuss recommendations for treatment in the community.
Is there Compensation for Participation?
The family will receive $100 for each major assessment completed. An additional $10 will be provided at each visit to cover travel and parking costs.
As noted earlier, there is no charge for the medical evaluation, study medication, and/or treatment sessions that are provided as part of the TADS study.
Who is Sponsoring this Study?
At Duke, the Prinicipal Investigator is John March, MD
The Project Leader is Deborah Hilgenberg, MPH
The Principal Statistician is Susan Silva, PhD
Study Locations and Contact Information and/or call, toll-free, 1-866-458-7425 (1-866-45TRIAL)