The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear Healthy Controls.

NCT01733030 | Completed

• 1 other identifier: MH080130
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

PROJECT SUMMARY: PTSD is a debilitating psychiatric condition precipitated by exposure to extreme, or life threatening, trauma with an estimated lifetime prevalence between 8% and 9% in U.S. adults. One core symptom of PTSD is intense psychological distress in the presence of stimuli that "resemble" one or more aspects of the trauma experience (DSM-IV). This phenomenon referred to as stimulus generalization has received surprisingly little empirical testing in the context of clinical anxiety in general, and PTSD more specifically. The current proposal represents the first effort to study the neurobiology and pharmacology of this PTSD-relevant learning phenomenon across those with and without PTSD. The objective of this particular proposal is to apply fMRI and pharmacologic methods to: 1) identify brain mechanisms associated with generalization of conditioned fear and 2) examine the pharmacologic modifiability of levels of generalization using a partial agonist at the NMDA receptor complex (D-cycloserine) shown to increase discrimination of CS+ (danger cue) and CS- (safety cue) in animal studies.

Conditions

Post Traumatic Stress Syndrome

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• fMRI (BOLD) responses

  fMRI (BOLD) responses

  1/1/13-6/1/14

Secondary Outcomes (1)

• Behavioral assessments of perceived danger

  up to three years

Study Arms (3)

250 mg Seromycin

Healthy adults who will receeve one administration of 250 mg of Seromycin prior to the start of the study.

Drug: Seromycin

500 mg Seromycin

Healthy adults who will recieve one administration of 500 mg of Seromycin prior to the start of the study.

Drug: Seromycin

Placebo

Healthy adults who will receive one administration of a placebo pill prior to the start of the study.

Interventions

Seromycin DRUG

250 mg versus 500 mg versus placebo effects on conditioned fear generalization

Also known as: D-cycloserine

250 mg Seromycin; 500 mg Seromycin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults between the ages of 18-55.

You may qualify if:

• Healthy adults between the ages of 18-55.

You may not qualify if:

• Current or past Axis I psychiatric diagnosis as determined by self report
• Current substance dependence or meet criteria for the six month period preceding testing.
• Participants will be excluded if they have current or past medical illnesses, which place the participant at risk or confound the results of the study including:
• A) Past history of hypersensitivity to Seromycin B) Current or past epileptic disorders C) Current depression D) Current anxiety disorders E) Current or past psychotic disorders F) Current or past renal disease G) Excessive or concurrent use of alcohol
• a) Subjects who are unable to abstain from alcohol for 12 hours prior to testing and 2 days following testing will be excluded
• Current use of psychoactive medications or medications that alter central-nervous-system function
• Females who are pregnant or currently breast-feeding
• Any metallic implants or objects above the knee, tattoos about the knee, or oral braces.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of MInnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Shmuel Lissek, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 26, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)