An Adaptive Treatment Strategy for Adolescent Depression-Continuation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-10-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Adolescent Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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6 IPT-A Sessions

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) only.

During the Continuation IPT-A sessions, the therapist will continue to emphasize the interpersonal strategies that were learned and practiced during the acute phase, and address any current interpersonal problems before they result in a recurrence of depressive symptoms. Adolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions.

Group Type ACTIVE_COMPARATOR

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

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

6 IPT-A Sessions + Continue Current Dose of Fluoxetine

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment.

Adolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions and will continue their acute phase fluoxetine dosing regimen and will meet with the psychiatrist on a monthly basis.

Group Type ACTIVE_COMPARATOR

Fluoxetine

Intervention Type DRUG

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

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

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

10 IPT-A Sessions + Begin Fluoxetine

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment.

Adolescents who received only IPT-A during acute phase and who showed a partial response (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will begin treatment with fluoxetine during the continuation phase.The dosage schedule will be 10mg per day for the first week and 20mg per day for the following 5 weeks. If no treatment response is observed by the 6th week, the dosage can be increased to 40mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and biweekly thereafter. Pharmacotherapy sessions will include assessment of vital signs, adverse effects, safety, and symptomatic response.

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

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

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

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

10 IPT-A Sessions + Increase Dose of Fluoxetine

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment.

Adolescents who received IPT-A and fluoxetine during the acute phase and were partial responders (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will have their fluoxetine dose increased to 60mg. Partial responders will meet with the psychiatrist biweekly for the first 2 months and monthly for the second 2 months.

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

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

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

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

Interventions

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Fluoxetine

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

Intervention Type DRUG

Interpersonal Psychotherapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Prozac IPT

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No