Status:
COMPLETED
Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
19-64 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to investigate the safety and efficacy of topiramate in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as measured by the Clini...
Detailed Description
Psychopharmacologic treatment of PTSD has been informed by only limited empirical data. Prior to the recently completed multi-site trials for sertraline conducted by Pearlstein and colleagues which fo...
Eligibility Criteria
Inclusion
- Subjects must have a diagnosis of PTSD as defined by DSM-IV for at least six months, supported by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
- Subjects must be female between 19 and 64 years of age, inclusive.
- Subjects must have a minimum past week CAPS score of 50 at Visit 2 (Day 1).
- Subjects must be in generally good health as confirmed by medical history, baseline psychiatric history and physical examination, including vital signs.
- Subjects must have observed the designated washout periods for prohibited medications outlined under the Concomitant Therapy section of this protocol.
- Subjects must have a negative urine drug screening (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at Visit 1.
- Subjects must:
- be postmenopausal for at least one year, or
- have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or
- have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility or
- be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.
- If (c) or (d), subjects must have a negative urine pregnancy test up to one week prior to Visit 2 (Day 1).
- Subjects must be able to take oral medication, adhere to medication regimens and be willing to return for regular visits.
- Subjects must be able to read and comprehend written instructions and willing to complete all scales and inventories required by this protocol.
Exclusion
- Subjects who have a DSM-IV diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within the past 3 months.
- Subjects with a current or past history of primary major depressive disorder or major anxiety disorder (i.e., panic disorder, obsessive-compulsive disorder, social phobia) as defined by DSM-IV.
- Subjects with a current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV.
- Subjects with a DSM-IV diagnosis of current organic mental disorder, factitious disorder, or malingering.
- Subjects who are currently enrolled in a cognitive-behavioral therapy program.
- Note: Subjects may be receiving concurrent psychotherapy (other than cognitive-behavioral therapy), but subjects must not initiate new psychotherapy treatment during their participation in the trial.
- Subjects with prior non-response to topiramate for the treatment of PTSD following an adequate trial.
- Subjects with a disability or other compensation claim pending for lack of functioning due to PTSD.
- Subjects with disability compensation dependent on persisting functional impairment related to PTSD.
- Subjects who have previously been treated with topiramate and discontinued treatment due to an adverse event or subjects with a known hypersensitivity to topiramate.
- Subjects with clinically unstable disease: cardiovascular, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease that could interfere with their participation in the study.
- Subjects with a history of nephrolithiasis.
- Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the normal range at Screening.
- Subjects who have active liver disease.
- Subjects taking antipsychotics within three months of the screening visit.
- Subjects with progressive or degenerative neurologic disorders (e.g., multiple sclerosis).
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00208130
Start Date
October 1 2001
End Date
March 1 2004
Last Update
April 29 2009
Active Locations (1)
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1
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131