PTAD GIA: An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02017535
Collaborator
(none)
15
1
4
76
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
A Personalized Approach to Achieving a Sustained Response to Treatment for Adolescent Depression
Actual Study Start Date
:
Jun 1, 2012
Actual Primary Completion Date
:
Oct 1, 2018
Actual Study Completion Date
:
Oct 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Behavioral: Interpersonal Psychotherapy
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Other Names:
|
| Active Comparator: 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. |
Drug: Fluoxetine
Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.
Other Names:
Behavioral: Interpersonal Psychotherapy
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Other Names:
|
| Experimental: 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. |
Drug: Fluoxetine
Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.
Other Names:
Behavioral: Interpersonal Psychotherapy
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Other Names:
|
| Experimental: 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. |
Drug: Fluoxetine
Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.
Other Names:
Behavioral: Interpersonal Psychotherapy
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Children's Depression Rating Scale-Revised (CDRS-R) [16 weeks, 32 weeks]
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.
- Children's Global Assessment Scale (CGAS) [16 weeks, 32 weeks]
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.
- Beck Depression Inventory-II (BDI-II) [16 weeks, 32 weeks]
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.
- Social Adjustment Scale - Self Report (SAS-SR) [16 weeks, 32 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota, Department of Psychiatry | Minneapolis | Minnesota | United States | 55454 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Meredith Gunlicks-Stoessel, PhD, University of Minnesota
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02017535
Other Study ID Numbers:
- 1206M15365
First Posted:
Dec 20, 2013
Last Update Posted:
Mar 23, 2020
Last Verified:
Mar 1, 2020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine |
|---|---|---|---|---|
| Arm/Group Description | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. |
| Period Title: Overall Study | ||||
| STARTED | 9 | 3 | 2 | 1 |
| COMPLETED | 8 | 3 | 2 | 1 |
| NOT COMPLETED | 1 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine | Total |
|---|---|---|---|---|---|
| Arm/Group Description | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | Total of all reporting groups |
| Overall Participants | 8 | 3 | 2 | 1 | 14 |
| Age (Count of Participants) | |||||
| <=18 years |
8
100%
|
3
100%
|
2
100%
|
1
100%
|
14
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
15.25
(1.91)
|
15
(1.73)
|
13
(1.41)
|
16
(NA)
|
14.93
(1.82)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
7
87.5%
|
2
66.7%
|
1
50%
|
1
100%
|
11
78.6%
|
| Male |
1
12.5%
|
1
33.3%
|
1
50%
|
0
0%
|
3
21.4%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
1
100%
|
1
7.1%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
7
87.5%
|
2
66.7%
|
2
100%
|
0
0%
|
11
78.6%
|
| More than one race |
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
1
7.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
8
100%
|
3
100%
|
2
100%
|
1
100%
|
14
100%
|
Outcome Measures
| Title | Children's Depression Rating Scale-Revised (CDRS-R) |
|---|---|
| Description | 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. |
| Time Frame | 16 weeks, 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine |
|---|---|---|---|---|
| Arm/Group Description | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. |
| Measure Participants | 8 | 3 | 2 | 1 |
| 16 Weeks |
32.38
(7.31)
|
26.67
(7.23)
|
51
(4.24)
|
45
(NA)
|
| 32 Weeks |
29
(7.07)
|
33.33
(5.51)
|
29
(9.9)
|
51
(NA)
|
| Title | Children's Global Assessment Scale (CGAS) |
|---|---|
| Description | 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. |
| Time Frame | 16 weeks, 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine |
|---|---|---|---|---|
| Arm/Group Description | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. |
| Measure Participants | 8 | 3 | 2 | 1 |
| 16 weeks |
65
(4)
|
77
(8)
|
53
(4)
|
55
(NA)
|
| 32 weeks |
72
(10)
|
71
(10)
|
72
(5)
|
49
(NA)
|
| Title | Beck Depression Inventory-II (BDI-II) |
|---|---|
| Description | 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. |
| Time Frame | 16 weeks, 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine |
|---|---|---|---|---|
| Arm/Group Description | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. |
| Measure Participants | 8 | 3 | 2 | 1 |
| 16 weeks |
7.63
(4.27)
|
11.33
(12.66)
|
10
(14.14)
|
NA
(NA)
|
| 32 weeks |
5.86
(3.67)
|
9
(10.82)
|
1.5
(2.12)
|
41
(NA)
|
| Title | Social Adjustment Scale - Self Report (SAS-SR) |
|---|---|
| Description | 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. |
| Time Frame | 16 weeks, 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine |
|---|---|---|---|---|
| Arm/Group Description | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. |
| Measure Participants | 8 | 3 | 2 | 1 |
| 16 weeks |
2.03
(.49)
|
2.07
(.22)
|
2.75
(.67)
|
NA
(NA)
|
| 32 weeks |
2.17
(.55)
|
1.62
(.46)
|
2.18
(.17)
|
3.09
(NA)
|
Adverse Events
| Time Frame | 32 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine | ||||
| Arm/Group Description | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | ||||
All Cause Mortality |
||||||||
| 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/3 (0%) | 0/2 (0%) | 0/1 (0%) | ||||
Serious Adverse Events |
||||||||
| 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/3 (0%) | 0/2 (0%) | 0/1 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| 6 IPT-A Sessions | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/3 (0%) | 0/2 (0%) | 0/1 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Meredith Gunlicks-Stoessel |
|---|---|
| Organization | University of Minnesota |
| Phone | 612-273-9844 |
| mgunlick@umn.edu |
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02017535
Other Study ID Numbers:
- 1206M15365
First Posted:
Dec 20, 2013
Last Update Posted:
Mar 23, 2020
Last Verified:
Mar 1, 2020