An Adaptive Treatment Strategy for Adolescent Depression

NCT01802437 | Completed Phase 1 Results DMC

• 1 other identifier: 1110M05542
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is:

1. 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. 2.to compare two ways of providing treatment to teenagers who have not improved enough.

Conditions

Adolescent Depression

Outcome Measures

Primary Outcomes (3)

• CDRS-R Score

  The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.

  Baseline and 16-weeks

• CGAS Score

  The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.

  Baseline and 16-weeks

• SAS-SR Score

  The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.

  Baseline and 16-weeks

Study Arms (2)

Talk Therapy 4-Week Decision Point

EXPERIMENTAL

Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy

Drug: Fluoxetine; Behavioral: Increased Dose of Interpersonal Psychotherapy; Behavioral: Continue to Receive Initial Dose of Interpersonal Psychotherapy

Talk Therapy 8-Week Decision Point

EXPERIMENTAL

Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.

Drug: Fluoxetine; Behavioral: Increased Dose of Interpersonal Psychotherapy; Behavioral: Continue to Receive Initial Dose of Interpersonal Psychotherapy

Interventions

Fluoxetine DRUG

If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increase in therapy (4 extra therapy sessions) or fluoxetine therapy. Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. If no treatment response was observed by the sixth week, the dosage could be increased to 40 mg per day.

Also known as: Prozac

Talk Therapy 4-Week Decision Point; Talk Therapy 8-Week Decision Point

Increased Dose of Interpersonal Psychotherapy BEHAVIORAL

If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increased dose of interpersonal psychotherapy (4 extra therapy sessions) or fluoxetine.

Talk Therapy 4-Week Decision Point; Talk Therapy 8-Week Decision Point

Continue to Receive Initial Dose of Interpersonal Psychotherapy BEHAVIORAL

If Hamilton Rating Scale for Depression scores meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be assigned to continue initial dose of interpersonal psychotherapy.

Talk Therapy 4-Week Decision Point; Talk Therapy 8-Week Decision Point

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota, Department of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Interventions

Fluoxetine

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Meredith Gunlicks-Stoessel
• Organization: University of Minnesota

mgunlick@umn.edu

612-273-9844

Study Officials

• Meredith Gunlicks-Stoessel, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: March 1, 2013
• Study Start: November 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-07

Locations

US (1)