Post Traumatic Stress SyndromeDCSNCT01733030
The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear Healthy Controls.
An observational study of Post Traumatic Stress Syndrome, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Syndrome
- What is being tested?
- Seromycin
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 1 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults between the ages of 18-55.
Who may be able to join
- Healthy adults between the ages of 18-55.
Who cannot join
- 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:
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of MInnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear in Healthy Controls.
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.
Read the detailed description
To fullfill the objectives of this application, a generalization paradigm has been designed and psychophysiologically validated in which 6 rings presented on a computer screen gradually increase in size. For half of participants the smallest ring is the conditioned stimulus paired with electric shock (CS+) and the largest is the unpaired stimulus (CS-), and for the other half of participants this is reversed. Activity in fear-related brain structures measured via fMRI are predicted to gradually decrease as the presented stimulus gradually becomes less similar to the CS+, forming a generalization slope or gradient. One central hypothesis of the current application is that DCS (Seromycin) will dose dependently increase the steepness of generalization gradients (i.e., reduce fear generalization). This study will include 3 groups of healthy adults recieving either 1) 500 mg Seromycin, 2) 250 mg Seromycin, or placebo only prior to acquisition of fear conditioning. Twenty four hours later, participants will return to complete an fMRI during which brain responses to the danger cue and stimuli resembling the danger cue will be assessed.
- Conditions
- Post Traumatic Stress Syndrome
- Being tested
- Seromycin
- Keywords
- PTSD
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeromycinDrug
Also called D-cycloserine
250 mg versus 500 mg versus placebo effects on conditioned fear generalization
SeromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| 250 mg Seromycin | Healthy adults who will receeve one administration of 250 mg of Seromycin prior to the start of the study. Receives: Drug: Seromycin | |
| 500 mg Seromycin | Healthy adults who will recieve one administration of 500 mg of Seromycin prior to the start of the study. Receives: Drug: Seromycin | |
| Placebo | Healthy adults who will receive one administration of a placebo pill prior to the start of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI (BOLD) responses
fMRI (BOLD) responses
Measured: 1/1/13-6/1/14
Secondary outcomes (1)
Behavioral assessments of perceived danger
Behavioral assessments of perceived danger
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startJan 2013
- Primary completion1 Oct 2015
- Study completion1 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shmuel Lissek, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733030
- Sponsor's protocol ID
- MH080130
- Acronym
- DCS
- Status last verified
- May 2017
- First submitted
- 19 Nov 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear in Healthy Controls.
- ClinicalTrials.gov ID
- NCT01733030
- Acronym / sponsor ID
- DCS / MH080130
- Conditions
- Post Traumatic Stress Syndrome
- Keywords
- PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Oct 2015 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To fullfill the objectives of this application, a generalization paradigm has been designed and psychophysiologically validated in which 6 rings presented on a computer screen gradually increase in size. For half of participants the smallest ring is the conditioned stimulus paired with electric shock (CS+) and the largest is the unpaired stimulus (CS-), and for the other half of participants this is reversed. Activity in fear-related brain structures measured via fMRI are predicted to gradually decrease as the presented stimulus gradually becomes less similar to the CS+, forming a generalization slope or gradient. One central hypothesis of the current application is that DCS (Seromycin) will dose dependently increase the steepness of generalization gradients (i.e., reduce fear generalization). This study will include 3 groups of healthy adults recieving either 1) 500 mg Seromycin, 2) 250 mg Seromycin, or placebo only prior to acquisition of fear conditioning. Twenty four hours later, participants will return to complete an fMRI during which brain responses to the danger cue and stimuli resembling the danger cue will be assessed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 250 mg Seromycin | – | Drug: SeromycinHealthy adults who will receeve one administration of 250 mg of Seromycin prior to the start of the study. |
| 500 mg Seromycin | – | Drug: SeromycinHealthy adults who will recieve one administration of 500 mg of Seromycin prior to the start of the study. |
| Placebo | – | –Healthy adults who will receive one administration of a placebo pill prior to the start of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults between the ages of 18-55.
Key inclusion criteria (1 listed)
- Healthy adults between the ages of 18-55.
Key exclusion criteria (8 listed)
- 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:
- Current use of psychoactive medications or medications that alter central-nervous-system function
- Females who are pregnant or currently breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeromycinAlso: D-cycloserine250 mg versus 500 mg versus placebo effects on conditioned fear generalization | Drug | 250 mg Seromycin, 500 mg Seromycin |
| Seromycin | Drug | 250 mg Seromycin, 500 mg Seromycin |
Primary outcome
fMRI (BOLD) responses
Time frame: 1/1/13-6/1/14
fMRI (BOLD) responses
1 secondary outcome
Behavioral assessments of perceived danger
Time frame: up to three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Lissek, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Syndrome, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI (BOLD) responses (time frame: 1/1/13-6/1/14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.