PhobiasPhase 2NCT00591825
fMRI Study Examining Effects of D-cycloserine in Specific Phobia
A Phase 2 study testing D-cycloserine in people with Phobias, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The research team hopes to use brain imaging and mental testing to learn more about specific phobias and the treatment of phobia. When given directly prior to therapy sessions, D-cycloserine has been shown to enhance the effects of therapy. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobias
- What is being tested?
- D-cycloserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Right-handed
- Adults between 18 and 55 years of age
- Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for spider phobia.
- Individuals of both genders and all races will be included
Who cannot join
- Women who are breastfeeding or pregnant
- Individuals with medical conditions unsuitable for MR scanning
- Individuals reporting a history of epilepsy or seizures
- Individuals reporting an allergy to cycloserine
- Individuals diagnosed with asthma or who report previous anaphylactic reaction to insect stings/bites, medication, food, or other material and/or event
- Individuals reporting present or past diagnosis of a developmental disorder, neurological disorder, or head injury *Individuals found to have Axis I psychopathology as defined by the DSM-IV (other than spider phobia)
- Individuals currently taking any psychotropic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center, Hoglund Brain Imaging Center
Kansas City, Kansas, 66160
About this study
Official title: An fMRI Study Investigating the Effects of Acute D-cycloserine Administration on Brain Activations and Cognitive Functioning in Spider Phobia.
The research team hopes to use brain imaging and mental testing to learn more about specific phobias and the treatment of phobia. When given directly prior to therapy sessions, D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify reasons why D-cycloserine has this effect by measuring brain activity.
Read the detailed description
Exposure and Response Prevention (ERP) therapy has become the treatment of choice for specific phobias. ERP involves systematic and repeated exposure to a feared or anxiety-provoking stimulus, leading to habituation and extinction of the fear response. Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS) prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in human subjects with height phobia (a specific phobia) has also demonstrated that DCS facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear extinction by enhancing the learning process and increasing consolidation of memories, but the neural mechanisms underlying this process are not understood. The proposed research aims to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation and verbal recognition one week post-medication. This research will also examine the effects of DCS on cognitive functioning using neuropsychological testing both two house and one week post-medication.
- Conditions
- Phobias
- Being tested
- D-cycloserine, Placebo
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called Cycloserine
D-cycloserine
PlaceboDrug
Also called Sugar pill
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Non-Phobic Control - Placebo | Placebo comparator | Participants without phobia will be given one placebo administration. Receives: Drug: Placebo |
| Non-Phobic Control - DCS | Active comparator | Participants without phobia will be given one D-cycloserine (DCS) administration of 100mg. Receives: Drug: D-cycloserine |
| Spider-phobic Placebo | Placebo comparator | Participants with phobia will be given one placebo administration. Receives: Drug: Placebo |
| Spider-phobic DCS | Experimental | Participants with phobia will be given one D-cycloserine (DCS) administration of 100mg. Receives: Drug: D-cycloserine |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Brain Activations During Symptom Provocation
Regions of interest (ROIs) were specified based on previous research and included amygdala, insula, dorsal anterior cingulate cortex (ACC), dorsolateral PFC (dlPFC), and hippocampus. Multiple regression analyses were used to examine differences in response between experimental conditions (spider versus butterfly images). For significant clusters of activation within ROIs, the average max percent signal change is reported. For other regions, the average max percent signal change is reported within a sphere centered at coordinates identified via previous research.
Measured: 2 Weeks
Secondary outcomes (4)
Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests)
This scale measures the learning and memory of functioning adults. Logical Memory I and II and Faces I and II subtests were administered to participants. The tasks measure verbal and visual memory, respectively. Scoring is based on the number of story details or faces correctly recalled during immediate (Logical Memory I, Faces I) and 30 minute delayed (Logical Memory II, Faces II) conditions. Total score ranges from 0-75 on Logical Memory I, 0-50 on Logical Memory II, 0-48 on Faces I, and 0-48 on Faces II. For all subtests, higher scores indicate better memory performance.
Measured: 2 Weeks
Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT)
The RCFT assesses the a person's ability to use cues to retrieve information. The test measures visuospatial construction and memory. A person is asked to draw a figure. The figure is broken down into 18 elements. The score is based on their presence, completeness, and correct placement. Each element is scored from 0-2. The Copy, Immediate, and Delay results are scored on a 36 point scale. The higher the score, the better the person performed on the test with a 0 being the minimum and 36 being the maximum score. The organization score is scored according to whether the participant drew five cohesive units of the figure together, for a range of 0-6 and a higher score indicating better organizational performance.
Measured: 2 weeks
Cognitive Functioning Measured Using the Iowa Gambling Test
This test measures a person's emotional decision making. Participants are presented with virtual decks of cards on a computer. Participants are told that each card they draw will "win" them game money. However, sometimes cards result in "losing" game money. The task includes 100 trials and the total score represents the number of cards drawn from "bad" decks as compared to "good" or safe decks. Thus, the score ranges from -100 to +100, with higher sores representing better performance.
Measured: 2 weeks
Cognitive Functioning Measured Using the Wisconsin Card Sorting Task
The Wisconsin Card Sorting Task measures executive functioning and cognitive flexibility. The task uses a deck of 64 cards that the participant must sort according to specified rules. The test is stopped when when six sequences of 10 correct responses have been achieved, or after the deck has been completed twice, which provides a cumulative total of 128 trials. We report the number of errors on the task, which has a range of 0 -128, with a higher score representing worse performance.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PhobiasStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation, American Psychological Association (APA)
- Responsible party
- Principal investigator, Cary Savage, Ph.D., University of Kansas
- Investigators
- Cary Savage, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591825
- Sponsor's protocol ID
- 10362
- Other IDs
- GCRC 0046, HSCL 15970
- Status last verified
- Jun 2017
- First submitted
- 27 Dec 2007
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An fMRI Study Investigating the Effects of Acute D-cycloserine Administration on Brain Activations and Cognitive Functioning in Spider Phobia.
- ClinicalTrials.gov ID
- NCT00591825
- Acronym / sponsor ID
- 10362
- Conditions
- Phobias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- American Psychological Foundation, American Psychological Association (APA)
- Study start
- Mar 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research team hopes to use brain imaging and mental testing to learn more about specific phobias and the treatment of phobia. When given directly prior to therapy sessions, D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify reasons why D-cycloserine has this effect by measuring brain activity.
Detailed description
Exposure and Response Prevention (ERP) therapy has become the treatment of choice for specific phobias. ERP involves systematic and repeated exposure to a feared or anxiety-provoking stimulus, leading to habituation and extinction of the fear response. Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS) prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in human subjects with height phobia (a specific phobia) has also demonstrated that DCS facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear extinction by enhancing the learning process and increasing consolidation of memories, but the neural mechanisms underlying this process are not understood. The proposed research aims to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation and verbal recognition one week post-medication. This research will also examine the effects of DCS on cognitive functioning using neuropsychological testing both two house and one week post-medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Phobic Control - Placebo | Placebo comparator | Drug: PlaceboParticipants without phobia will be given one placebo administration. |
| Non-Phobic Control - DCS | Active comparator | Drug: D-cycloserineParticipants without phobia will be given one D-cycloserine (DCS) administration of 100mg. |
| Spider-phobic Placebo | Placebo comparator | Drug: PlaceboParticipants with phobia will be given one placebo administration. |
| Spider-phobic DCS | Experimental | Drug: D-cycloserineParticipants with phobia will be given one D-cycloserine (DCS) administration of 100mg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Right-handed
- Adults between 18 and 55 years of age
- Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for spider phobia.
- Individuals of both genders and all races will be included
Key exclusion criteria (7 listed)
- Women who are breastfeeding or pregnant
- Individuals with medical conditions unsuitable for MR scanning
- Individuals reporting a history of epilepsy or seizures
- Individuals reporting an allergy to cycloserine
- Individuals diagnosed with asthma or who report previous anaphylactic reaction to insect stings/bites, medication, food, or other material and/or event
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 |
|---|---|---|
| D-cycloserineAlso: CycloserineD-cycloserine | Drug | Non-Phobic Control - DCS, Spider-phobic DCS |
| PlaceboAlso: Sugar pillPlacebo | Drug | Non-Phobic Control - Placebo, Spider-phobic Placebo |
Primary outcome
fMRI Brain Activations During Symptom Provocation
Time frame: 2 Weeks
Regions of interest (ROIs) were specified based on previous research and included amygdala, insula, dorsal anterior cingulate cortex (ACC), dorsolateral PFC (dlPFC), and hippocampus. Multiple regression analyses were used to examine differences in response between experimental conditions (spider versus butterfly images). For significant clusters of activation within ROIs, the average max percent signal change is reported. For other regions, the average max percent signal change is reported within a sphere centered at coordinates identified via previous research.
4 secondary outcomes
Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests)
Time frame: 2 Weeks
Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT)
Time frame: 2 weeks
Cognitive Functioning Measured Using the Iowa Gambling Test
Time frame: 2 weeks
Cognitive Functioning Measured Using the Wisconsin Card Sorting Task
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Cary Savage, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-cycloserine in people with Phobias, run by University of Kansas Medical Center 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 4 inclusion and 7 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 5 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Brain Activations During Symptom Provocation (time frame: 2 Weeks). 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 5 Jun 2017.