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Phase 4 Completed N=91 Randomized Quadruple-blind Other

Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753)

Stress Disorder, Post Traumatic
Source: ClinicalTrials.gov NCT02560389 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Galvanic Skin Response — .37; .29; .36 Unitless
◆ Published Evidence
Emerging
12citations · ~2 / year
Unique neurocircuitry activation profiles during fear conditioning and extinction among women with posttraumatic stress disorder.
Journal of psychiatric research · 2021 · Likely link

Summary

The purpose of this study is to investigate a new use for a medication called levodopa (L-DOPA). L-DOPA has been approved for use in Parkinson 's disease, but not for Posttraumatic Stress Disorder (PTSD). L-DOPA is thought to enhance certain cognitive abilities that the investigators believe may be affected among women with PTSD. It is hypothesized that L-DOPA may enhance fear extinction learning to a conditioned fear stimulus. If this is true, L-DOPA may improve outcomes for those undergoing certain types of therapy for PTSD, though that aim is beyond the scope of this project. Additionally, the investigators are testing whether an individual's genetic profile affects how well L-DOPA works to enhance cognitive abilities.

Linked Publications

  • Unique neurocircuitry activation profiles during fear conditioning and extinction among women with posttraumatic stress disorder.
    Journal of psychiatric research · 2021 · 12 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Galvanic Skin Response
.37; .29; .36
SECONDARY
Percentage Change in Functional Activation of Amygdala
-0.1; -0.06; -0.05
SECONDARY
Functional Activation of Anterior Cingulate Cortex
0.08; 0.09; 0.07

Eligibility Criteria

Inclusion Criteria

  • 25-50 years of age
  • PTSD related to physical or sexual assault
  • Medically healthy
  • English speaking

Exclusion Criteria

  • Claustrophobia, or the inability to lie still in a confined space
  • Major medical disorders (e.g., HIV, cancer)
  • Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents)
  • Electronic or magnetic implants, such as pacemakers
  • Permanent makeup or tattoos with metallic dyes
  • Currently pregnant
  • A self-reported history of loss of consciousness (greater than 10 minutes)
  • Physical disabilities that prohibit task performance (such as blindness or deafness)
  • Psychotic disorders (e.g., schizophrenia)
  • Any other condition that the investigator believes might put the participant at risk
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02560389) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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