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BCBT, SMHC referral

Phase 2

Depression | Unknown | Psychiatry |Johnson & Johnson|Last Updated: Apr 30, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00669526Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing DisordersPHASE2 COMPLETED 60Oct 1, 2004Apr 1, 2007Apr 30, 20081 United States
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Study Endpoints
Primary Endpoints
Clinician Global Impressions - Improvement (CGI-I)
weeks 12 and 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SMHC referralACTIVE_COMPARATORReferral to local Specialty Mental Health Care Services
BCBTEXPERIMENTALBrief Cognitive Behavioral Therapy
Interventions
NameTypeDescription
BCBTBEHAVIORALBrief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.
SMHC referralBEHAVIORALReferral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.).
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Eligibility Criteria
Age Range7 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria for depression: * Ages 11 to 17 years * Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression * Live with a legal guardian Inclusion Criteria for anxiety: * Ages 7 to 17 years * Meet full or probable (missing one, non-core symptom) diagnostic criteria fo...

Countries:United States
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