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Completed

NCT Number: NCT02017535

An Adaptive Treatment Strategy for Adolescent Depression-Continuation

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.

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Key information

Conditions

Adolescent Depression

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Minnesota, Department of Psychiatry

Minneapolis, Minnesota, 55454, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoxetine

Drug

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

Other names: Prozac

interpersonal psychotherapy

Behavioral

Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.

Other names: IPT

Primary outcomes

  1. Children's Depression Rating Scale-Revised (CDRS-R)

    Time frame: 16 weeks, 32 weeks

    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.

  2. Children's Global Assessment Scale (CGAS)

    Time frame: 16 weeks, 32 weeks

    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.

  3. Beck Depression Inventory-II (BDI-II)

    Time frame: 16 weeks, 32 weeks

    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.

  4. Social Adjustment Scale - Self Report (SAS-SR)

    Time frame: 16 weeks, 32 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: PTAD GIA

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2013
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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