Phase 2
N=15
An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Adolescent Depression
Bottom Line
View on ClinicalTrials.gov: NCT02017535 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Children's Depression Rating Scale-Revised (CDRS-R) — 32.38; 26.67; 51; 45 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoxetine (Drug); Interpersonal Psychotherapy (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Depression Rating Scale-Revised (CDRS-R) |
32.38; 26.67; 51; 45; 29; 33.33 | — |
| PRIMARY Children's Global Assessment Scale (CGAS) |
65; 77; 53; 55; 72; 71 | — |
| PRIMARY Beck Depression Inventory-II (BDI-II) |
7.63; 11.33; 10; NA; 5.86; 9 | — |
| PRIMARY Social Adjustment Scale - Self Report (SAS-SR) |
2.03; 2.07; 2.75; NA; 2.17; 1.62 | — |
Summary
Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy.
Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment.
Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.
Eligibility Criteria
Inclusion Criteria
- Adolescents and parents must be English-speaking
- Completed acute phase treatment (NCT01802437) and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)).
Exclusion Criteria
- Did not completed acute phase treatment (NCT01802437) or did not show at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)) to acute phase treatment.
Data sourced from ClinicalTrials.gov (NCT02017535). 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.