Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians

NCT00208130 | Completed Phase 4

• 1 other identifier: CAPSS-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 Clinician-Administered PTSD Scale (CAPS) for DSM-IV.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD; trauma

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable for this study will be the change of the 17-item total severity score of the CAPS from baseline to the last visit of Double-Blind Phase.

Secondary Outcomes (1)

• The secondary efficacy variables consist of changes from baseline to the last visit in Double-Blind Phase of HARS, Ham-D, TOP-8 and CGI at the last visit of Double-Blind Phase.

Interventions

Topiramate DRUG

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Creighton University Psychiatry and Research Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

• Monga V, Petty F, Padala K, Padala PR. Topiramate Monotherapy for Civilian Posttraumatic Stress Disorder: A Controlled Pilot Study. Prim Care Companion CNS Disord. 2023 Oct 19;25(5):23m03555. doi: 10.4088/PCC.23m03555.

  PMID: 37857291 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Frederick Petty, MD, PhD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2001
• Study Completion: March 1, 2004
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

US (1)