Phase 2
N=40
An Adaptive Treatment Strategy for Adolescent Depression
Adolescent Depression
Bottom Line
View on ClinicalTrials.gov: NCT01802437 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
Jul 2019
Primary outcome: Primary: CDRS-R Score — 34.94; 40.65 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoxetine (Drug); Increased Dose of Interpersonal Psychotherapy (Behavioral); Continue to Receive Initial Dose of Interpersonal Psychotherapy (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CDRS-R Score |
34.94; 40.65 | — |
| PRIMARY CGAS Score |
66.52; 60.66 | — |
| PRIMARY SAS-SR Score |
2.16; 2.35 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01802437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.