Clinical trial NCT01802437: An Adaptive Treatment Strategy for Adolescent Depression
Official title: An Adaptive Treatment Strategy for Adolescent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Adolescent Depression
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is:

1. to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for depression should get therapy before the therapist decides whether or not the teenager is improving enough, and
2. to compare two ways of providing treatment to teenagers who have not improved enough.

Detailed description: Study Procedures

This study has three phases:

1. The screening and eligibility phase:

   Parent and child will conduct an initial evaluation that will last about 4 hours. The evaluator will ask questions and the participant will complete forms about his/her mood and behavior. This intake appointment will determine eligibility for the study.
2. The treatment phase: The child would begin a kind of talk therapy called interpersonal psychotherapy. The goal of the therapy is to decrease teenagers' depression by helping them improve their relationships and communication skills. The child will attend 12 therapy appointments over the course of 16 weeks. Each appointment will be 50 minutes long.

   If the child is doing well with standard interpersonal therapy, it will be continued without change. If the child has not improved enough, we will change the treatment plan in one of two ways. The choice will be based on chance (sort of like flipping a coin) and will be done by a computer.

   \*\*\*Your child will attend 16 therapy appointments (that is four additional sessions). These additional four sessions will be scheduled so that your child will attend therapy twice a week for a period of four weeks.

   -OR-

   \*\*\*Your child will continue to attend 12 therapy appointments over the course of 16 weeks and your child will also be prescribed an antidepressant medication called fluoxetine. Fluoxetine is also known as Prozac. Prozac has been approved by the Food and Drug Administration for use in the treatment of depressed teenagers. You will be responsible for paying for the medication.

   At four points during the treatment phase (week 4, week 8, week 12, and week 16), parent and child will be asked to complete forms and interviews to see how the child is doing. The evaluations at weeks 4, 8, and 12 will take approximately 1 hour. At the end of treatment, parent and child will have a longer meeting with the evaluator (4 hours) to see if the treatment your child got was helpful. During these meetings, we will also ask participants to fill out some forms about your mood and mental health treatment.
3. The follow-up phase: Parent and child will be asked to return for a follow-up assessment 4 months after the child completes the treatment phase to see how he or she is doing. Parent and child will be asked to complete forms and interviews. This meeting will take approximately 4 hours.

Eligibility criteria: Inclusion Criteria:

* Adolescent meets DSM-IV-TR criteria for a diagnosis of Major Depressive Disorder, Dysthymia, or Depressive Disorder NOS; demonstrate symptoms of depression (CDRS-R \> 35); and demonstrate impairment in general functioning (CGAS \< 65).
* Adolescents and parents must be English-speaking

Exclusion Criteria:

* Adolescent meets criteria for a diagnosis of Schizophrenia, Bipolar Disorder, Psychosis, Substance Abuse, OCD, Conduct Disorder, Eating Disorder, PDD, or intellectual disability disorder.
* Depressed adolescents who are actively suicidal with a plan and/or intent
* Adolescent that are already receiving treatment for depression or if they are taking medication for a psychiatric diagnosis other than ADHD. Depressed adolescents with a comorbid diagnosis of ADHD who are on a stable dose of stimulant medication (\> 3 months) will be eligible to participate in the studies.
* Adolescent that have already received an adequate trial of IPT-A or fluoxetine.
* Female adolescents who are pregnant, breastfeeding, or having unprotected sexual intercourse.

Primary outcomes:
measure: CDRS-R Score
timeFrame: Baseline and 16-weeks
measure: CGAS Score
timeFrame: Baseline and 16-weeks
measure: SAS-SR Score
timeFrame: Baseline and 16-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Psychiatry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Meredith Gunlicks-Stoessel, PhD
role: PRINCIPAL_INVESTIGATOR
References: