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Report for Clinical Trial NCT00632632

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder

This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder (PTSD) following either the events of September 11, 2001, or military service in the war in Iraq. In addition, this study hopes to determine whether a common human genetic single nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF (Val66Met), predicts treatment response to PTSD. Overall, this study aims 1) to determine if subjects administered DCS show a significantly larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to determine if subjects administered DCS show a decrease in PTSD symptomatology significantly earlier (as measured by weeks) than those administered a placebo, 3) to determine if differences in symptomatology are evident at a 6-month follow-up and indicate long-term differences between groups, and 4) to determine if the BDNF SNP predicts treatment response.

NCT00632632 Posttraumatic Stress Disorder
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

2 Interventions

Name: D-Cycloserine

Description: Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Type: Drug
Group Labels: 1

D-Cycloserine (DCS)

Name: Placebo

Description: Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times).
Type: Other
Group Labels: 1

Placebo


Primary Outcomes

Description: Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score. Subscales: CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)

Measure: Clinician Administered PTSD Scale(CAPS)

Time: Immediately following treatment

Description: Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score. Subscales: CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)

Measure: Clinician Administered PTSD Scale(CAPS)

Time: 6-months follow-up

Secondary Outcomes

Description: Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.

Measure: Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)

Time: Immediately following treatment

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V66M

In addition, this study hopes to determine whether a common human genetic single nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF (Val66Met), predicts treatment response to PTSD. --- Val66Met ---



HPO Nodes