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Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD)

NCT00766064 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-08-23

No results posted yet for this study

Summary

Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Antidepressants, including selective serotonin reuptake inhibitors (SRIs) or norepinephrine-serotonin re-uptake inhibitors are considered treatment of first choice for these patients, however a substantial portion of patients do not respond sufficiently (Zhang and Davidson 2007). Therefore, there is a need to establish novel and effective add-on treatment strategies for these patients. Recently, atypical neuroleptics have received considerable attention since it was shown in multiple controlled and naturalistic trials that these medications are an effective treatment option for patients with PTSD (Davis et al 2006). In chronic PTSD, the psychophysiological responses at baseline and in response to treatment have yet been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of medications used in the treatment of PTSD. Therefore, in addition to evaluating the antidepressant and anxiolytic effects of paliperidone, a novel atypical neuroleptic, in the treatment of PTSD, we also aim to compare neurophysiological responses at baseline with post-treatment effects in antidepressant-refractory PTSD patients.

Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of paliperidone in patients with PTSD.

Secondary Aim 2: Evaluate the effects of paliperidone on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 6 weeks of naturalistic treatment in chronic PTSD patients.

Conditions

Interventions

DRUG

Paliperidone

Paliperidone will be gradually increased to a final dose between 3 - 6 mg/day according to the following schedule: Weeks 1 - 3: 3 mg daily, Weeks 4 - 5: flexible dosing according clinical situation, dose range between 3 mg - 6 mg daily\*, Week 6: fixed dose, \*Criteria to increase the dose from 3 mg to 6 mg daily are 1\] absence of any side effects, 2\] patients not showing a sufficient response to 3 mg paliperidone can be increased to 6 mg daily. Response is defined as change in depression and anxiety ratings of at least 30% compared to baseline.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Alexander Neumeister, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766064 on ClinicalTrials.gov