Clinical trial NCT01492699: Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder
Official title: Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Post Traumatic Stress Disorder
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

1. Male and female subjects between ages 18-55
2. The subject has signed and dated the written informed consent to participate in the study
3. The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
4. The subject meets criteria for PTSD as defined by the DSM-IV-TR
5. Stable use of clinically prescribed medications
6. Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation
7. 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 Criteria:

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

Primary outcomes:
measure: Change in adverse events from baseline
timeFrame: weekly for 4 weeks then every 4 weeks until week 14
Secondary outcomes:
measure: Change from baseline in PTSD and mood related symptoms
timeFrame: weekly for 4 weeks then every 4 weeks until week 14
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
Study officials:
affiliation: Resilience Government Services, Inc.
name: John Abernethy, MD
role: STUDY_DIRECTOR
References: