An Adaptive Treatment Strategy for Adolescent Depression-Continuation

Adolescent Depression Clinical Trial

— PTAD GIA  

Official title:

A Personalized Approach to Achieving a Sustained Response to Treatment for Adolescent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017535
• Other study ID #: 1206M15365
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2012
• Est. completion date: October 1, 2018

Study information

• Verified date: March 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Male and female adolescents (ages 12-18) will be eligible for the study if they completed acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)). Adolescents will enter continuation treatment having either received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus fluoxetine.This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent Depression (PTAD)" NCT01802437

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Fluoxetine
Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.

Behavioral:
• Interpersonal Psychotherapy
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.

Locations

Country	Name	City	State
United States	University of Minnesota, Department of Psychiatry	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Rating Scale-Revised (CDRS-R)	The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity.	16 weeks, 32 weeks
Primary	Children's Global Assessment Scale (CGAS)	The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning.	16 weeks, 32 weeks
Primary	Beck Depression Inventory-II (BDI-II)	BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.	16 weeks, 32 weeks
Primary	Social Adjustment Scale - Self Report (SAS-SR)	The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning.	16 weeks, 32 weeks