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Cognitive-behavioral therapy and paroxetine

Phase 2

Stress Disorders, Post-Traumatic | Small molecule | Psychiatry |GSK plc|Last Updated: May 30, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

Cognitive-behavioral therapy and paroxetine · 1 trial · 1 indication

Phase 2 1
NCT00215163Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure TherapyStress Disorders, Post-Traumatic
COMPLETED17 Analytics
PHASE2COMPLETED
Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy
Stress Disorders, Post-TraumaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Short PTSD Rating Interview (SPRINT)
Davidson Trauma Scale (DTS)

Secondary Endpoints

Clinical Global Impressions Severity Scale (CGI-S)
Clinical Global Impressions Improvement Scale (CGI-I)
Posttraumatic Diagnostic Scale (PDS)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Cognitive-behavioral therapy and paroxetine-CRDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria * Patients must have remained symptomatic (CGI-S \> or = 3) and a score of at l...

Countries:United States
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Frequently asked questions about Cognitive-behavioral therapy and paroxetine

What is Cognitive-behavioral therapy and paroxetine used for?

Cognitive-behavioral therapy and paroxetine is used for post-traumatic stress disorder (PTSD). It is being studied as a combination treatment for PTSD that remains symptomatic after initial exposure therapy. The drug is a small molecule developed by GSK plc and is currently in Phase 2 clinical development.

Who makes Cognitive-behavioral therapy and paroxetine?

Cognitive-behavioral therapy and paroxetine is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The therapy combines cognitive-behavioral therapy with the drug paroxetine, and it is being investigated for the treatment of post-traumatic stress disorder.

What phase is Cognitive-behavioral therapy and paroxetine in?

Cognitive-behavioral therapy and paroxetine is in Phase 2 clinical development. It is an investigational therapy for post-traumatic stress disorder and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is Cognitive-behavioral therapy and paroxetine in?

Cognitive-behavioral therapy and paroxetine has been studied in one clinical trial, identified as NCT00215163. This Phase 2 trial, titled "Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy," was completed in the United States. The trial enrolled 17 participants aged 18 years and older.

Is Cognitive-behavioral therapy and paroxetine the same as paroxetine?

Cognitive-behavioral therapy and paroxetine is a combination therapy that includes paroxetine, specifically paroxetine-CR (controlled release), along with cognitive-behavioral therapy. While paroxetine is a component of the treatment, the full therapy refers to the combined approach being studied for post-traumatic stress disorder.