Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder

Completed · Not applicable

Conditions studied: Post Traumatic Stress Disorder

In brief

This is a clinical study for adult subjects with Post Traumatic Stress Disorder.

Key facts

Study ID

NCT01492699

Run by

Alachua Government Services, Inc.

People needed

7

Starts

2012-06-01

Expected to finish

2013-06-01

Last updated by the study team

2014-09-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects between ages 18-55
• The subject has signed and dated the written informed consent to participate in the study
• The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
• The subject meets criteria for PTSD as defined by the DSM-IV-TR
• Stable use of clinically prescribed medications
• Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation
• Female subjects - not surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).

You may not qualify if…

• Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria
• Patient actively suicidal within last 12-months or with current suicidal ideation
• History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview
• Participation in a clinical drug research study within the past 30 days
• Subject currently taking any SSRI or anti-depressant medication.
• Pregnant or breastfeeding females
• Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary.

Where it is running

• Sarkis Clinical Trials — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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