An Adaptive Treatment Strategy for Adolescent Depression (PTAD)
10. července 2019 aktualizováno: University of Minnesota
The purpose of the study is:
- 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
- to compare two ways of providing treatment to teenagers who have not improved enough.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
Study Procedures
This study has three phases:
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.
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.
- 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.
Typ studie
Intervenční
Zápis (Aktuální)
40
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55454
- University of Minnesota, Department of Psychiatry
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
12 let až 17 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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
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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.
Ostatní jména:
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.
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.
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Experimentální: 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.
|
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.
Ostatní jména:
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.
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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CDRS-R Score
Časové okno: 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.
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Baseline and 16-weeks
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CGAS Score
Časové okno: Baseline and 16-weeks
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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.
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Baseline and 16-weeks
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SAS-SR Score
Časové okno: Baseline and 16-weeks
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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.
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Baseline and 16-weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Meredith Gunlicks-Stoessel, PhD, University of Minnesota
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2010
Primární dokončení (Aktuální)
1. června 2016
Dokončení studie (Aktuální)
1. června 2016
Termíny zápisu do studia
První předloženo
1. února 2013
První předloženo, které splnilo kritéria kontroly kvality
27. února 2013
První zveřejněno (Odhad)
1. března 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. července 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. července 2019
Naposledy ověřeno
1. července 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Symptomy chování
- Duševní poruchy
- Poruchy nálady
- Deprese
- Deprese
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Psychotropní drogy
- Inhibitory vychytávání serotoninu
- Inhibitory vychytávání neurotransmiterů
- Membránové transportní modulátory
- Serotoninové látky
- Antidepresiva
- Inhibitory enzymu cytochromu P-450
- Antidepresiva, druhá generace
- Cytochrom P-450 Inhibitory CYP2D6
- Fluoxetin
Další identifikační čísla studie
- 1110M05542
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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