N/A Completed N=25 Randomized Quadruple-blind Treatment

Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)

Posttraumatic Stress Disorder

Source: ClinicalTrials.gov NCT00632632 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2015

Primary outcomePrimary: Clinician Administered PTSD Scale(CAPS) — 32.38; 42.17 units on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinician Administered PTSD Scale(CAPS)	24.15; 45.92	—
PRIMARY Clinician Administered PTSD Scale(CAPS)	24.15; 45.92	—
SECONDARY Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)	78; 60	—

Eligibility Criteria

Inclusion Criteria

English-speaking adults
Between the ages of 18 and 70
Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
Diagnosed with PTSD symptoms.

Exclusion Criteria

Presence of current organic mental disorder
Schizophrenia
Bipolar disorder
Depression with psychotic features
Current substance dependence
Delusional disorder
Active suicidal ideation, intent, or plan
Active homicidal ideation, intent, or plan
Use of pacemaker
Medically unstable
Pregnant or lactating
A history of severe renal disease
History of seizures
Currently taking anticoagulants, ethionamide (Trecator-SC) or isoniazid (INH)
History of allergic reaction to cycloserine.

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Data sourced from ClinicalTrials.gov (NCT00632632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.