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| ID | Type | Description | Link |
|---|---|---|---|
| GCRC 0046 | Other Identifier | University of Kansas Medical Center | |
| HSCL 15970 | Other Identifier | University of Kansas |
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| Name | Class |
|---|---|
| American Psychological Foundation | OTHER |
| American Psychological Association (APA) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Phobic Control - Placebo | Placebo Comparator | Participants without phobia will be given one placebo administration. |
|
| Non-Phobic Control - DCS | Active Comparator | Participants without phobia will be given one D-cycloserine (DCS) administration of 100mg. |
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| Spider-phobic Placebo | Placebo Comparator | Participants with phobia will be given one placebo administration. |
|
| Spider-phobic DCS | Experimental | Participants with phobia will be given one D-cycloserine (DCS) administration of 100mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-cycloserine | Drug | D-cycloserine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cary Savage, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center, Hoglund Brain Imaging Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Phobic Control - Placebo | Participants without phobia given one administration placebo. |
| FG001 | Non-Phobic Control - DCS | Participants without phobia given one administration of 100 mg D-cycloserine (DCS). |
| FG002 | Spider-phobic Placebo | Participants with phobia given one administration of placebo. |
| FG003 | Spider-phobic DCS | Participants with phobia given one administration of 100 mg D-cycloserine (DCS). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Phobic Control - Placebo | Participants without phobia given one administration of placebo. |
| BG001 | Non-Phobic Control - DCS | Participants without phobia given one administration of 100 mg D-cycloserine (DCS). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | There were 54 enrolled in the study. 8 subjects were excluded from fMRI analyses: 1 for claustrophobia, 3 for scanner artifact, 1 because of motion >3mm; 3 of paradigm-consistent motion which could not be corrected for. | Posted | Mean | Standard Deviation | percent signal change | 2 Weeks |
|
At the end of each session, approximately 4-6 hours after drug administration. Participants were monitored through study completion, an average of 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Phobic Control - Placebo | Participants without phobia were given one administration placebo. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Aupperle, PhD | Laureate Institute for Brain Research (LIBR) | (913) 588-9078 | raupperle@laureateinstitute.org |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo |
|
|
| 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. | 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. | 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. | 2 weeks |
| BG002 | Spider-phobic Placebo | Participants with phobia given one administration of placebo. |
| BG003 | Spider-phobic DCS | Participants with phobia given one administration of 100 mg D-cycloserine (DCS). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
| OG001 | DCS Control | Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS). |
| OG002 | Placebo Phobic | Participants with phobia who were randomized to the Placebo group were given one administration of placebo. |
| OG003 | Placebo Control | Participants without phobia who were randomized to the Placebo group were given one administration of placebo. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | 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. | Two subjects did not complete the test because they had previous exposure to the test. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Non-Phobic Control - DCS | Participants without phobia were given one administration 100 mg D-cycloserine (DCS). | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Spider-phobic Placebo | Participants with phobia were given one administration placebo. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Spider-phobic DCS | Participants with phobia were given one administration 100 mg D-cycloserine (DCS). | 0 | 13 | 0 | 14 | 0 | 14 |
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |
| Logical Memory 2 |
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| Faces 1 |
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| Faces 2 |
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| Copy |
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| Immediate |
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| Delay |
|