Status:
COMPLETED
Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This is a clinical study for adult subjects with Post Traumatic Stress Disorder.
Detailed Description
Open label clinical study to evaluate the efficacy of PRX-03140 in reducing PTSD symptoms
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01492699
Start Date
June 1 2012
End Date
June 1 2013
Last Update
September 25 2014
Active Locations (1)
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1
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607