Trial Outcomes & Findings for An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression (NCT NCT03222570)

NCT ID: NCT03222570

Last Updated: 2025-07-02

Results Overview

Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	IPT-A Adaptive Treatment Strategy Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI). Interpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions. Selective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline	Usual Care Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI. Usual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI
Overall Study STARTED	57	33
Overall Study COMPLETED	40	27
Overall Study NOT COMPLETED	17	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Baseline characteristics by cohort

Measure	IPT-A Adaptive Treatment Strategy n=57 Participants Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI). Interpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions. Selective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline	Usual Care n=33 Participants Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI. Usual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	57 Participants n=5 Participants	33 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.8 years STANDARD_DEVIATION 1.6 • n=5 Participants	14.2 years STANDARD_DEVIATION 2.0 • n=7 Participants	14.6 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	21 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	24 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	24 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	33 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome

Outcome measures

Measure	IPT-A Adaptive Treatment Strategy n=57 Participants Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI). Interpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions. Selective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline	Usual Care n=33 Participants Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI. Usual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI
Children's Depression Rating Scale - Revised	36.0 score on a scale Standard Deviation 11.3	37.5 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: 16 weeks

Measure of general psychosocial functioning Minimum score: 1 Maximum score: 100 A higher score indicates a better outcome

Outcome measures

Measure	IPT-A Adaptive Treatment Strategy n=57 Participants Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI). Interpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions. Selective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline	Usual Care n=33 Participants Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI. Usual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI
Children's Global Assessment Scale	61.8 score on a scale Standard Deviation 9.5	63.3 score on a scale Standard Deviation 12.1

Adverse Events

IPT-A Adaptive Treatment Strategy

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IPT-A Adaptive Treatment Strategy n=57 participants at risk Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI). Interpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions. Selective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline	Usual Care n=33 participants at risk Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI. Usual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI
Psychiatric disorders Emergent or worsening suicidal ideation	17.5% 10/57 • 16 weeks	15.2% 5/33 • 16 weeks

Additional Information

Meredith Gunlicks-Stoessel

University of Minnesota

Phone: 612-624-9249

Email: mgunlick@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place