A Placebo-Controlled Trial of D-Cycloserine and Exposure Therapy for Combat-PTSD

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this project is to examine whether administration of D-Cycloserine (DCS), a partial N-methyl-D-aspartate (NMDA) receptor agonist that has been shown to facilitate fear extinction, enhances the therapeutic benefit of exposure-based cognitive behavioral therapy (CBT) in OEF/OIF veterans with PTSD.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Cycloserine

Criteria

Inclusion Criteria:

• Male or female outpatients 18 years of age or older who served in Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) and who have a primary diagnosis (designated by the patient as the most important source of distress of PTSD.

• Willingness and ability to comply with the requirements of the study protocol.

Exclusion Criteria:

A lifetime history of:

• bipolar disorder

• schizophrenia

• psychosis

• delusional disorders or obsessive-compulsive disorder

• organic brain syndrome

• cognitive dysfunction that could interfere with capacity to engage in therapy

• a history of substance or alcohol dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.

• Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate services.

• Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.

• Serious medical illness or instability for which hospitalization may be likely within the next year.

• Patients with a current or past history of seizures

• Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., intra uterine device, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).

• Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration specifically targeting PTSD is excluded. General supportive therapy initiated > 3 months prior is acceptable.

• Patients with seizures or ongoing severe cognitive impairment that compromised mental status.

• Patients receiving Isoniazid.

• Patients unable to understand study procedures and participate in the informed consent process.

• Patients with a history of renal insufficiency (creatinine clearance less than 50 mL/min).