Adults 18 to 50, any sex, with Posttraumatic Stress Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change Clinical-Administered Post Traumatic - DSM-5Primary· Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Standard administration and scoring of the CAPS-5 are essential for producing reliable and valid scores and diagnostic decisions. Clinical-Administered Post Traumatic -DSM-5 (CAPS-5) 30 items, score ranging from 0-50. CAPS-5 symptom severity ratings are based on symptom frequency and intensity. Intensity rating of Minimal corresponds to a severity rating of Mild/subthreshold, Clearly Present corresponds with Moderate/threshold, Pronounced corresponds with Severe/markedly elevated, and Extreme corresponds with Extreme/ incapacitating. Administered at baseline and after 30 rTMS treatment.
Group
Value
95% CI
Right Slow Prefrontal rTMS
-9.4
± 14.5
Right Fast Prefrontal rTMS
-10.9
± 11.7
Change in IPF: Inventory of Psychosocial FunctioningPrimary· Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Change Inventory of Psychosocial Functioning (IPF) Administered at baseline and after 30 rTMS treatments. The IPF is an 80 question self-report scale that assessed function in the areas of family, work,friendships and socializing, parenting, education, self-care, and romantic relationships with spouse or partner. The rate is based on how often participant acted over the past 30 days. Domains are averaged with resulting score range 1 - 7. 1 Never - 7 Always.
Group
Value
95% CI
Right Slow Prefrontal rTMS
-0.40
± 0.77
Right Fast Prefrontal rTMS
-0.50
± 0.58
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 weeks of treatment and at 3-month post treatment evaluation.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. The secondary objectives include: one, testing which treatment provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; three, testing which treatment is better tolerated as measured by participant drop out and side effect profiles.
Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.
Methodology: Veterans 18-50 years of age suffering from PTSD with and without depressive symptoms will be recruited from the community as well as mental health clinics at James A. Haley Veterans Administration Hospital. Plan to enroll 50 to have an evaluable sample of approximately 20 in each group. Participants will be consented and undergo screening for safety and appropriateness to be in the trial. Those deemed eligible will be evaluated with clinical measures of function, PTSD, depression, pain, and neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by significant depression defined as MADRS greater than 19) to one of two active treatments: right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo assessment for safety prior to each treatment. The treatments will be performed 5 days a week for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per week. Clinical evaluations will be performed at baseline, after every five treatments, at the end of treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a significant difference in change in depressive symptoms for both the participants with significant depressive symptoms and the entire group. The number of dropouts (related specifically to side effects and all cause) will be used along with side effect profiles to test for differences in tolerability of the two treatments.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by James A. Haley Veterans Administration Hospital
Last refreshed: 27 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02158663.