Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment for Adolescents With Depression Study (TADS)
Brief Summary: TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.

The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?

The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.

The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.


Options:
A: Inclusion Criteria:

* Primary diagnosis DSM-IV of Major Depressive Disorder, pervasive and stable; Children's Depression Rating Scale-R total score at least 45; Ages 12-17 inclusive; Grade in school: 6-12; Full-Scale IQ at least 80; Medication-free before start of study; Outpatient; Parent (or family member) involvement

Exclusion Criteria:

* Bipolar disorder; Severe Conduct Disorder; Substance Use/Abuse/Dependence; Pervasive Developmental Disorders; Thought Disorder; Suicidality or homicidality; Concurrent treatment with psychotropic drug (stable stimulant for ADHD permitted) or psychotherapy outside study; Two previous failed SSRI trials or a failed trial of CBT for depression; Intolerance to fluoxetine; Non-English speaking patient; Pregnancy or breastfeeding; No phone in home; Lack of parent or family member)involvement.
B: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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
C: Inclusion Criteria:

* Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
* Patient's current depressive episode must be at least 12 weeks in duration
* Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.

Exclusion Criteria:

* Patients who currently meet DSM-IV criteria for:

  1. attention deficit-hyperactivity disorder
  2. obsessive-compulsive disorder
  3. posttraumatic stress disorder
  4. bipolar disorder
  5. pervasive developmental disorder
  6. mental retardation
  7. conduct disorder
  8. oppositional defiant disorder
* Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
D: Inclusion Criteria:

* Age 13-19
* Diagnosis of Major Depression

Exclusion Criteria:

* History of mania/hypomania
* Current psychotic symptoms
* Substance dependence
* Medical conditions (contraindication for sertraline)
* Pregnancy
* Past treatment with sertraline

Answer: A