Safety & Efficacy Study Using Topiramate in Posttraumatic Stress Disorder

NCT00204386 | Completed Phase 2 DMC

• 2 other identifiers: CAPSS-205IRB#10198
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine if Topiramate was safe and effective for use in civilian subjects with Posttraumatic Stress Disorder.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Total CAPS Scale Score change from baseline/visit 2. CAPS administered at 5,7 and 9

  12 weeks

Secondary Outcomes (1)

• CGI Scale at visit 2 through 9; HARS at visit 2,4,5,7 and 9; HAM-D at visit 2,4,5,7 and 9; DTS at visits 2,4,5,7 and 9; TOP 8 at visits 2, 4-9; SDS visits 2-9; SVS visits 2-9

  12 weeks

Interventions

Topiramate DRUG

Eligibility Criteria

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

You may qualify if:

• PTSD as defined by DSM-IV for at least 6 months supported by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I);
• Subjects must have a minimum past week CAPS score of \> than 50 at Visit 2;
• Subjects must be in general good health as confirmed by medical history, and physical examination;
• Subjects must be off prohibited medications for washout periods as outlined under Concomitant Therapy section;
• Subjects must have negative urine drug screen (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at visit 1;
• Subjects must either be postmenopausal for at least 1 year,have had a hysterectomy or tubal ligation, be otherwise incapable of pregnancy or have practiced one of the following methods of contraception for at least one month prior to enrollment: 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.
• Subjects must be able to take oral medication, adhere to medication regiments and be willing to return for regular visits;
• After full explanation of the study, subjects must demonstrate their willingness to participate by signing an informed consent form.

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 current or past history of primary major depressive disorder or primary major anxiety disorder (i.e. panic disorder, obsessive-compulsive disorder, social phobia) as defined by DSM-IV;
• Subjects with current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder;
• Subjects with diagnosis of current organic mental disorder, factitious disorder or malingering
• Subjects with diagnosis of bulimia or anorexia nervosa;
• Subjects who are currently enrolled in cognitive-behavioral therapy;
• Subjects with current disability compensation or claim pending for persisting functional impairment related to PTSD;
• Subjects with prior non-response to topiramate for the treatment of PTSD following an adequate trial.
• 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 history of nephrolithiasis;
• Subjects with SGOT and/or SGPT levels greater than 2 times the upper limit of normal range at screening;
• Subjects taking antipsychotics within 3 months of the screening visit;
• Subjects with progressive or degenerative neurologic disorders (e.g. multiple sclerosis);
• Subjects with active liver disease;

Sponsors & Collaborators

• University of Oklahoma: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Study Sites (1)

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

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

• Phebe M Tucker, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2002
• Study Completion: May 1, 2007
• Last Updated: May 30, 2007

Record last verified: 2007-05

Locations

US (1)