Depressive DisorderPhase 2NCT03222570
An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression
A Phase 2 study testing Interpersonal Psychotherapy for Depressed Adolescents and Selective Serotonin Reuptake Inhibitor in people with Depressive Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Interpersonal Psychotherapy for Depressed Adolescents and Selective Serotonin Reuptake Inhibitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 28 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC
- Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised [CDRS-R])
- Current impairment in psychosocial functioning (based on Children's Global Assessment Scale [CGAS])
Who cannot join
- Non English-speaking
- Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder.
- Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study.
- Currently taking medication for a psychiatric diagnosis other than ADHD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.
- Conditions
- Depressive Disorder
- Being tested
- Interpersonal Psychotherapy for Depressed Adolescents, Selective Serotonin Reuptake Inhibitor, Usual Care
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for Depressed AdolescentsBehavioural
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 InhibitorDrug
Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline
Usual CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| IPT-A Adaptive Treatment Strategy | Experimental | 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). Receives: Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; Drug: Selective Serotonin Reuptake Inhibitor |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Depression Rating Scale - Revised
Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome
Measured: 16 weeks
Secondary outcomes (1)
Children's Global Assessment Scale
Measure of general psychosocial functioning Minimum score: 1 Maximum score: 100 A higher score indicates a better outcome
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start26 Feb 2018
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222570
- Sponsor's protocol ID
- PSYCH-2017-25767
- Other IDs
- R01MH113748
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2017
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data resulting from the proposed project will be shared via the National Database for Clinical Trials (NDCT).
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression
- ClinicalTrials.gov ID
- NCT03222570
- Acronym / sponsor ID
- PSYCH-2017-25767
- Conditions
- Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Posted 2 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT-A Adaptive Treatment Strategy | Experimental | Behavioral: Interpersonal Psychotherapy for Depressed Adolescents, Drug: Selective Serotonin Reuptake InhibitorAdolescents 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). |
| Usual Care | Active comparator | Other: Usual CareTherapists 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC
- Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised [CDRS-R])
- Current impairment in psychosocial functioning (based on Children's Global Assessment Scale [CGAS])
Key exclusion criteria (4 listed)
- Non English-speaking
- Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder.
- Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study.
- Currently taking medication for a psychiatric diagnosis other than ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal Psychotherapy for Depressed AdolescentsIPT-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. | Behavioural | IPT-A Adaptive Treatment Strategy |
| Selective Serotonin Reuptake InhibitorFluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline | Drug | IPT-A Adaptive Treatment Strategy |
| Usual CareTherapists 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 | Other | Usual Care |
Primary outcome
Children's Depression Rating Scale - Revised
Time frame: 16 weeks
Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome
1 secondary outcome
Children's Global Assessment Scale
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data resulting from the proposed project will be shared via the National Database for Clinical Trials (NDCT).
Related trials for Depressive Disorder
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interpersonal Psychotherapy for Depressed Adolescents and Selective Serotonin Reuptake Inhibitor in people with Depressive Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Depression Rating Scale - Revised (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.