An Adaptive Treatment Strategy for Adolescent Depression-Continuation (PTAD GIA)

University of Minnesota (UMN)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Adolescent Depression

Treatments: Drug: Fluoxetine; Behavioral: Interpersonal Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02017535

1206M15365

Details and patient eligibility

About

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.

Full 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

Enrollment: 15 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 4 patient groups

6 IPT-A Sessions

Active Comparator group

Description:

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.

Treatment:

Behavioral: Interpersonal Psychotherapy

6 IPT-A Sessions + Continue Current Dose of Fluoxetine

Active Comparator group

Description:

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.

Treatment:

Behavioral: Interpersonal Psychotherapy

Drug: Fluoxetine

10 IPT-A Sessions + Begin Fluoxetine

Experimental group

Description:

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.

Treatment:

Behavioral: Interpersonal Psychotherapy

Drug: Fluoxetine

10 IPT-A Sessions + Increase Dose of Fluoxetine

Experimental group

Description:

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.

Treatment:

Behavioral: Interpersonal Psychotherapy

Drug: Fluoxetine