An Adaptive Treatment Strategy for Adolescent Depression-Continuation

Study Overview
=================
Brief 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.

Detailed 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

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

Conditions
-----------------
Adolescent Depression

Intervention / Treatment
-----------------
* Drug: Fluoxetine
* Behavioral: Interpersonal Psychotherapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 IPT-A Sessions<br>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. | Behavioral: Interpersonal Psychotherapy<br>* Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.<br>* Other names: IPT;|
| Active Comparator: 6 IPT-A Sessions + Continue Current Dose of Fluoxetine<br>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. | Drug: Fluoxetine<br>* Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.<br>* Other names: Prozac;Behavioral: Interpersonal Psychotherapy<br>* Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.<br>* Other names: IPT;|
| Experimental: 10 IPT-A Sessions + Begin Fluoxetine<br>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. | Drug: Fluoxetine<br>* Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.<br>* Other names: Prozac;Behavioral: Interpersonal Psychotherapy<br>* Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.<br>* Other names: IPT;|
| Experimental: 10 IPT-A Sessions + Increase Dose of Fluoxetine<br>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. | Drug: Fluoxetine<br>* Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.<br>* Other names: Prozac;Behavioral: Interpersonal Psychotherapy<br>* Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.<br>* Other names: IPT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |