Trial Outcomes & Findings for An Adaptive Treatment Strategy for Adolescent Depression-Continuation (NCT NCT02017535)
NCT ID: NCT02017535
Last Updated: 2020-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
16 weeks, 32 weeks
Results posted on
2020-03-23
Participant Flow
Participant milestones
| Measure |
6 IPT-A Sessions
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.
|
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
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.
|
10 IPT-A Sessions + Begin Fluoxetine
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.
|
10 IPT-A Sessions + Increase Dose of Fluoxetine
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
8
|
3
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
6 IPT-A Sessions
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.
|
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
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.
|
10 IPT-A Sessions + Begin Fluoxetine
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.
|
10 IPT-A Sessions + Increase Dose of Fluoxetine
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Baseline characteristics by cohort
| Measure |
6 IPT-A Sessions
n=8 Participants
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.
|
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
n=3 Participants
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.
|
10 IPT-A Sessions + Begin Fluoxetine
n=2 Participants
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.
|
10 IPT-A Sessions + Increase Dose of Fluoxetine
n=1 Participants
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
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
15.25 years
STANDARD_DEVIATION 1.91 • n=5 Participants
|
15 years
STANDARD_DEVIATION 1.73 • n=7 Participants
|
13 years
STANDARD_DEVIATION 1.41 • n=5 Participants
|
16 years
STANDARD_DEVIATION NA • n=4 Participants
|
14.93 years
STANDARD_DEVIATION 1.82 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
14 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 16 weeks, 32 weeksThe 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.
Outcome measures
| Measure |
6 IPT-A Sessions
n=8 Participants
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.
|
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
n=3 Participants
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.
|
10 IPT-A Sessions + Begin Fluoxetine
n=2 Participants
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.
|
10 IPT-A Sessions + Increase Dose of Fluoxetine
n=1 Participants
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.
|
|---|---|---|---|---|
|
Children's Depression Rating Scale-Revised (CDRS-R)
16 Weeks
|
32.38 score on a scale
Standard Deviation 7.31
|
26.67 score on a scale
Standard Deviation 7.23
|
51 score on a scale
Standard Deviation 4.24
|
45 score on a scale
Standard Deviation NA
Only one participant in this group, standard deviation can not be calculated.
|
|
Children's Depression Rating Scale-Revised (CDRS-R)
32 Weeks
|
29 score on a scale
Standard Deviation 7.07
|
33.33 score on a scale
Standard Deviation 5.51
|
29 score on a scale
Standard Deviation 9.9
|
51 score on a scale
Standard Deviation NA
Only one participant in this group, standard deviation can not be calculated.
|
PRIMARY outcome
Timeframe: 16 weeks, 32 weeksThe 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.
Outcome measures
| Measure |
6 IPT-A Sessions
n=8 Participants
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.
|
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
n=3 Participants
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.
|
10 IPT-A Sessions + Begin Fluoxetine
n=2 Participants
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.
|
10 IPT-A Sessions + Increase Dose of Fluoxetine
n=1 Participants
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.
|
|---|---|---|---|---|
|
Children's Global Assessment Scale (CGAS)
32 weeks
|
72 score on a scale
Standard Deviation 10
|
71 score on a scale
Standard Deviation 10
|
72 score on a scale
Standard Deviation 5
|
49 score on a scale
Standard Deviation NA
Only one participant in this group, standard deviation can not be calculated.
|
|
Children's Global Assessment Scale (CGAS)
16 weeks
|
65 score on a scale
Standard Deviation 4
|
77 score on a scale
Standard Deviation 8
|
53 score on a scale
Standard Deviation 4
|
55 score on a scale
Standard Deviation NA
Only one participant in this group, standard deviation can not be calculated.
|
PRIMARY outcome
Timeframe: 16 weeks, 32 weeksBDI-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.
Outcome measures
| Measure |
6 IPT-A Sessions
n=8 Participants
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.
|
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
n=3 Participants
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.
|
10 IPT-A Sessions + Begin Fluoxetine
n=2 Participants
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.
|
10 IPT-A Sessions + Increase Dose of Fluoxetine
n=1 Participants
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.
|
|---|---|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
16 weeks
|
7.63 score on a scale
Standard Deviation 4.27
|
11.33 score on a scale
Standard Deviation 12.66
|
10 score on a scale
Standard Deviation 14.14
|
NA score on a scale
Standard Deviation NA
Only one participant in this group; data point is missing.
|
|
Beck Depression Inventory-II (BDI-II)
32 weeks
|
5.86 score on a scale
Standard Deviation 3.67
|
9 score on a scale
Standard Deviation 10.82
|
1.5 score on a scale
Standard Deviation 2.12
|
41 score on a scale
Standard Deviation NA
Only one participant in this group; data point is missing.
|
PRIMARY outcome
Timeframe: 16 weeks, 32 weeksThe 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.
Outcome measures
| Measure |
6 IPT-A Sessions
n=8 Participants
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.
|
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
n=3 Participants
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.
|
10 IPT-A Sessions + Begin Fluoxetine
n=2 Participants
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.
|
10 IPT-A Sessions + Increase Dose of Fluoxetine
n=1 Participants
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.
|
|---|---|---|---|---|
|
Social Adjustment Scale - Self Report (SAS-SR)
16 weeks
|
2.03 score on a scale
Standard Deviation .49
|
2.07 score on a scale
Standard Deviation .22
|
2.75 score on a scale
Standard Deviation .67
|
NA score on a scale
Standard Deviation NA
Only one participant in this group; data point is missing.
|
|
Social Adjustment Scale - Self Report (SAS-SR)
32 weeks
|
2.17 score on a scale
Standard Deviation .55
|
1.62 score on a scale
Standard Deviation .46
|
2.18 score on a scale
Standard Deviation .17
|
3.09 score on a scale
Standard Deviation NA
Only one participant in this group; data point is missing.
|
Adverse Events
6 IPT-A Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 IPT-A Sessions + Begin Fluoxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 IPT-A Sessions + Increase Dose of Fluoxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place