PTAD: An Adaptive Treatment Strategy for Adolescent Depression

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01802437
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 67
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of the study is:

1. to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for depression should get therapy before the therapist decides whether or not the teenager is improving enough, and

2. to compare two ways of providing treatment to teenagers who have not improved enough.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Depression	Drug: Fluoxetine; Behavioral: Increased Dose of Interpersonal Psychotherapy; Behavioral: Continue to Receive Initial Dose of Interpersonal Psychotherapy	Phase 1/Phase 2

Detailed Description

Study Procedures

This study has three phases:

1. The screening and eligibility phase:

Parent and child will conduct an initial evaluation that will last about 4 hours. The evaluator will ask questions and the participant will complete forms about his/her mood and behavior. This intake appointment will determine eligibility for the study.

1. The treatment phase: The child would begin a kind of talk therapy called interpersonal psychotherapy. The goal of the therapy is to decrease teenagers' depression by helping them improve their relationships and communication skills. The child will attend 12 therapy appointments over the course of 16 weeks. Each appointment will be 50 minutes long.

If the child is doing well with standard interpersonal therapy, it will be continued without change. If the child has not improved enough, we will change the treatment plan in one of two ways. The choice will be based on chance (sort of like flipping a coin) and will be done by a computer.

***Your child will attend 16 therapy appointments (that is four additional sessions). These additional four sessions will be scheduled so that your child will attend therapy twice a week for a period of four weeks.

-OR-

***Your child will continue to attend 12 therapy appointments over the course of 16 weeks and your child will also be prescribed an antidepressant medication called fluoxetine. Fluoxetine is also known as Prozac. Prozac has been approved by the Food and Drug Administration for use in the treatment of depressed teenagers. You will be responsible for paying for the medication.

At four points during the treatment phase (week 4, week 8, week 12, and week 16), parent and child will be asked to complete forms and interviews to see how the child is doing. The evaluations at weeks 4, 8, and 12 will take approximately 1 hour. At the end of treatment, parent and child will have a longer meeting with the evaluator (4 hours) to see if the treatment your child got was helpful. During these meetings, we will also ask participants to fill out some forms about your mood and mental health treatment.

1. The follow-up phase: Parent and child will be asked to return for a follow-up assessment 4 months after the child completes the treatment phase to see how he or she is doing. Parent and child will be asked to complete forms and interviews. This meeting will take approximately 4 hours.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: An Adaptive Treatment Strategy for Adolescent Depression
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Talk Therapy 4-Week Decision Point Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy	Drug: Fluoxetine; If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increase in therapy (4 extra therapy sessions) or fluoxetine therapy. 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. If no treatment response was observed by the sixth week, the dosage could be increased to 40 mg per day.; Other Names: Prozac ; Behavioral: Increased Dose of Interpersonal Psychotherapy; If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increased dose of interpersonal psychotherapy (4 extra therapy sessions) or fluoxetine.; Behavioral: Continue to Receive Initial Dose of Interpersonal Psychotherapy; If Hamilton Rating Scale for Depression scores meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be assigned to continue initial dose of interpersonal psychotherapy.
Experimental: Talk Therapy 8-Week Decision Point Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.	Drug: Fluoxetine; If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increase in therapy (4 extra therapy sessions) or fluoxetine therapy. 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. If no treatment response was observed by the sixth week, the dosage could be increased to 40 mg per day.; Other Names: Prozac ; Behavioral: Increased Dose of Interpersonal Psychotherapy; If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increased dose of interpersonal psychotherapy (4 extra therapy sessions) or fluoxetine.; Behavioral: Continue to Receive Initial Dose of Interpersonal Psychotherapy; If Hamilton Rating Scale for Depression scores meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be assigned to continue initial dose of interpersonal psychotherapy.

Outcome Measures

Primary Outcome Measures

1. CDRS-R Score [Baseline and 16-weeks]

   The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.

2. CGAS Score [Baseline and 16-weeks]

   The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.

3. SAS-SR Score [Baseline and 16-weeks]

   The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adolescent meets DSM-IV-TR criteria for a diagnosis of Major Depressive Disorder, Dysthymia, or Depressive Disorder NOS; demonstrate symptoms of depression (CDRS-R > 35); and demonstrate impairment in general functioning (CGAS < 65).

• Adolescents and parents must be English-speaking

Exclusion Criteria:

• Adolescent meets criteria for a diagnosis of Schizophrenia, Bipolar Disorder, Psychosis, Substance Abuse, OCD, Conduct Disorder, Eating Disorder, PDD, or intellectual disability disorder.

• Depressed adolescents who are actively suicidal with a plan and/or intent

• Adolescent that are already receiving treatment for depression or if they are taking medication for a psychiatric diagnosis other than ADHD. Depressed adolescents with a comorbid diagnosis of ADHD who are on a stable dose of stimulant medication (> 3 months) will be eligible to participate in the studies.

• Adolescent that have already received an adequate trial of IPT-A or fluoxetine.

• Female adolescents who are pregnant, breastfeeding, or having unprotected sexual intercourse.

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)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01802437
• Other Study ID Numbers: 1110M05542
• First Posted: Mar 1, 2013
• Last Update Posted: Jul 11, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Depression; Depressive Disorder; Fluoxetine

Study Results

Participant Flow

Arm/Group Title	Talk Therapy 4-Week Decision Point	Talk Therapy 8-Week Decision Point
Arm/Group Description	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
Period Title: Overall Study
STARTED	20	20
COMPLETED	16	16
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Talk Therapy 4-Week Decision Point	Talk Therapy 8-Week Decision Point	Total
Arm/Group Description	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy. Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	20 100%	20 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.8 (1.8)	14.8 (1.8)	14.8 (1.7)
Sex: Female, Male (Count of Participants)
Female	16 80%	15 75%	31 77.5%
Male	4 20%	5 25%	9 22.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 15%	1 5%	4 10%
Not Hispanic or Latino	17 85%	19 95%	36 90%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 10%	1 5%	3 7.5%
Asian	1 5%	2 10%	3 7.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	16 80%	16 80%	32 80%
More than one race	1 5%	1 5%	2 5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%
Children's Depression Rating Scale-Revised Score (CDRS-R) (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	55.9 (10.4)	55.3 (11)	55.6 (10.5)
Children's Global Assessment Scale (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	50.4 (5.2)	51.6 (6.9)	51.0 (6.1)
Social Adjustment Scale-Self Report (SAS-SR) (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	2.8 (0.6)	2.7 (.7)	2.7 (0.6)

Outcome Measures

1. Primary Outcome

Title	CDRS-R Score
Description	The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.
Time Frame	Baseline and 16-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Talk Therapy 4-Week Decision Point	Talk Therapy 8-Week Decision Point
Arm/Group Description	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy. Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)
Measure Participants	20	20
Mean (Standard Error) [score on a scale]	34.94 (2.05)	40.65 (2.05)

2. Primary Outcome

Title	CGAS Score
Description	The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.
Time Frame	Baseline and 16-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Talk Therapy 4-Week Decision Point	Talk Therapy 8-Week Decision Point
Arm/Group Description	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy. Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)
Measure Participants	20	20
Mean (Standard Error) [score on a scale]	66.52 (2.39)	60.66 (2.39)

3. Primary Outcome

Title	SAS-SR Score
Description	The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.
Time Frame	Baseline and 16-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Talk Therapy 4-Week Decision Point	Talk Therapy 8-Week Decision Point
Arm/Group Description	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy. Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)
Measure Participants	20	20
Mean (Standard Error) [score on a scale]	2.16 (0.13)	2.35 (0.14)

Adverse Events

Time Frame	16-weeks
Arm/Group Title	Talk Therapy 4-Week Decision Point		Talk Therapy 8-Week Decision Point
Arm/Group Description	Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.		Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy. Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)
All Cause Mortality
	Talk Therapy 4-Week Decision Point		Talk Therapy 8-Week Decision Point
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Talk Therapy 4-Week Decision Point		Talk Therapy 8-Week Decision Point
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		2/20 (10%)
Psychiatric disorders
Suicide Attempt	2/20 (10%)		2/20 (10%)
Other (Not Including Serious) Adverse Events
	Talk Therapy 4-Week Decision Point		Talk Therapy 8-Week Decision Point
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/20 (55%)		12/20 (60%)
Psychiatric disorders
Harm-related	6/20 (30%)		8/20 (40%)
Suicide-Related	5/20 (25%)		4/20 (20%)

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.