Trial Outcomes & Findings for fMRI Study Examining Effects of D-cycloserine in Specific Phobia (NCT NCT00591825)

Last Updated: 2017-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

2 Weeks

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Phobic Control - Placebo Participants without phobia given one administration placebo.	Non-Phobic Control - DCS Participants without phobia given one administration of 100 mg D-cycloserine (DCS).	Spider-phobic Placebo Participants with phobia given one administration of placebo.	Spider-phobic DCS Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
Overall Study STARTED	14	13	13	14
Overall Study COMPLETED	14	13	13	14
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

fMRI Study Examining Effects of D-cycloserine in Specific Phobia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Phobic Control - Placebo n=14 Participants Participants without phobia given one administration of placebo.	Non-Phobic Control - DCS n=13 Participants Participants without phobia given one administration of 100 mg D-cycloserine (DCS).	Spider-phobic Placebo n=13 Participants Participants with phobia given one administration of placebo.	Spider-phobic DCS n=14 Participants Participants with phobia given one administration of 100 mg D-cycloserine (DCS).	Total n=54 Participants Total of all reporting groups
Age, Continuous	23.09 years STANDARD_DEVIATION 3.70 • n=93 Participants	26.75 years STANDARD_DEVIATION 9.09 • n=4 Participants	26.00 years STANDARD_DEVIATION 8.06 • n=27 Participants	24.73 years STANDARD_DEVIATION 6.65 • n=483 Participants	25.65 years STANDARD_DEVIATION 7.78 • n=36 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	9 Participants n=4 Participants	7 Participants n=27 Participants	13 Participants n=483 Participants	39 Participants n=36 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants	1 Participants n=483 Participants	15 Participants n=36 Participants

PRIMARY outcome

Timeframe: 2 Weeks

Population: 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.

Outcome measures

SECONDARY outcome

Timeframe: 2 Weeks

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.

Outcome measures

Outcome measures
Measure	DCS Phobic n=14 Participants Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	DCS Control n=13 Participants Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	Placebo Phobic n=13 Participants Participants with phobia who were randomized to the Placebo group were given one administration of placebo.	Placebo Control n=14 Participants Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests) Logical Memory 1	51.93 units on a scale Standard Deviation 8.91	49 units on a scale Standard Deviation 9.24	52.69 units on a scale Standard Deviation 10.30	52.93 units on a scale Standard Deviation 7.56
Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests) Logical Memory 2	34.36 units on a scale Standard Deviation 6.67	32.46 units on a scale Standard Deviation 7.03	34.85 units on a scale Standard Deviation 8.21	35.43 units on a scale Standard Deviation 5.20
Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests) Faces 1	40.43 units on a scale Standard Deviation 3.2	41.85 units on a scale Standard Deviation 2.73	41 units on a scale Standard Deviation 4.28	42.07 units on a scale Standard Deviation 3.83
Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests) Faces 2	41.93 units on a scale Standard Deviation 2.09	41.62 units on a scale Standard Deviation 2.99	41.62 units on a scale Standard Deviation 3.43	42.07 units on a scale Standard Deviation 3.97

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	DCS Phobic n=14 Participants Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	DCS Control n=13 Participants Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	Placebo Phobic n=13 Participants Participants with phobia who were randomized to the Placebo group were given one administration of placebo.	Placebo Control n=14 Participants Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT) Organization	4.93 units on a scale Standard Deviation 1.33	4.92 units on a scale Standard Deviation 1.55	3.69 units on a scale Standard Deviation 1.97	4.14 units on a scale Standard Deviation 1.96
Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT) Copy	34.68 units on a scale Standard Deviation 2.49	34.46 units on a scale Standard Deviation 3.53	34.46 units on a scale Standard Deviation 2.15	34.50 units on a scale Standard Deviation 1.95
Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT) Immediate	26.54 units on a scale Standard Deviation 3.97	24.77 units on a scale Standard Deviation 6.66	26.17 units on a scale Standard Deviation 3.76	26.14 units on a scale Standard Deviation 5.46
Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT) Delay	26.08 units on a scale Standard Deviation 3.81	23.35 units on a scale Standard Deviation 7.11	26.13 units on a scale Standard Deviation 2.57	25.64 units on a scale Standard Deviation 5.36

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	DCS Phobic n=14 Participants Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	DCS Control n=13 Participants Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	Placebo Phobic n=13 Participants Participants with phobia who were randomized to the Placebo group were given one administration of placebo.	Placebo Control n=14 Participants Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
Cognitive Functioning Measured Using the Iowa Gambling Test	44.29 units on a scale Standard Deviation 23.68	32.62 units on a scale Standard Deviation 26.76	28.58 units on a scale Standard Deviation 21.89	21.85 units on a scale Standard Deviation 28.42

SECONDARY outcome

Timeframe: 2 weeks

Population: Two subjects did not complete the test because they had previous exposure to the test.

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.

Outcome measures

Outcome measures
Measure	DCS Phobic n=14 Participants Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	DCS Control n=13 Participants Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	Placebo Phobic n=13 Participants Participants with phobia who were randomized to the Placebo group were given one administration of placebo.	Placebo Control n=12 Participants Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
Cognitive Functioning Measured Using the Wisconsin Card Sorting Task	13.29 units on a scale Standard Deviation 6.98	13.62 units on a scale Standard Deviation 7.65	18.23 units on a scale Standard Deviation 16.58	15.67 units on a scale Standard Deviation 9.33

Adverse Events

Non-Phobic Control - Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Phobic Control - DCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Spider-phobic Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Spider-phobic DCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robin Aupperle, PhD

Laureate Institute for Brain Research (LIBR)

Phone: (913) 588-9078

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DCS Phobic n=11 Participants Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	DCS Control n=12 Participants Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).	Placebo Phobic n=12 Participants Participants with phobia who were randomized to the Placebo group were given one administration of placebo.	Placebo Control n=11 Participants Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
fMRI Brain Activations During Symptom Provocation Left dlPFC Spider	.250 percent signal change Standard Deviation .183	.122 percent signal change Standard Deviation .361	.019 percent signal change Standard Deviation .118	.278 percent signal change Standard Deviation .300
fMRI Brain Activations During Symptom Provocation Left Insula Spider	.200 percent signal change Standard Deviation .182	.157 percent signal change Standard Deviation .373	-.013 percent signal change Standard Deviation .167	.036 percent signal change Standard Deviation .095
fMRI Brain Activations During Symptom Provocation Left Insula Butterfly	.012 percent signal change Standard Deviation .139	.021 percent signal change Standard Deviation .376	.092 percent signal change Standard Deviation .162	.079 percent signal change Standard Deviation .147
fMRI Brain Activations During Symptom Provocation Right Insula Spider	.107 percent signal change Standard Deviation .190	.174 percent signal change Standard Deviation .287	-.004 percent signal change Standard Deviation .087	.020 percent signal change Standard Deviation .250
fMRI Brain Activations During Symptom Provocation Right Insula Butterfly	.017 percent signal change Standard Deviation .144	.109 percent signal change Standard Deviation .221	.133 percent signal change Standard Deviation .139	.017 percent signal change Standard Deviation .211
fMRI Brain Activations During Symptom Provocation mid dorsal ACC Spider	.242 percent signal change Standard Deviation .135	.402 percent signal change Standard Deviation .459	.073 percent signal change Standard Deviation .171	.071 percent signal change Standard Deviation .180
fMRI Brain Activations During Symptom Provocation mid dorsal ACC Butterfly	.022 percent signal change Standard Deviation .114	.053 percent signal change Standard Deviation .166	.085 percent signal change Standard Deviation .123	-.059 percent signal change Standard Deviation .244
fMRI Brain Activations During Symptom Provocation Left dlPFC Butterfly	.031 percent signal change Standard Deviation .122	.076 percent signal change Standard Deviation .372	.035 percent signal change Standard Deviation .154	.075 percent signal change Standard Deviation .435
fMRI Brain Activations During Symptom Provocation Right dlPFC Spider	.384 percent signal change Standard Deviation .286	.521 percent signal change Standard Deviation .676	.301 percent signal change Standard Deviation .349	.038 percent signal change Standard Deviation .464
fMRI Brain Activations During Symptom Provocation Right dlPFC Butterfly	.150 percent signal change Standard Deviation .203	.431 percent signal change Standard Deviation .585	.249 percent signal change Standard Deviation .420	.110 percent signal change Standard Deviation .310
fMRI Brain Activations During Symptom Provocation Left amygdala Spider	.322 percent signal change Standard Deviation .182	.202 percent signal change Standard Deviation .308	.534 percent signal change Standard Deviation .272	.427 percent signal change Standard Deviation .244
fMRI Brain Activations During Symptom Provocation Left amygdala Butterfly	.127 percent signal change Standard Deviation .139	.149 percent signal change Standard Deviation .137	.254 percent signal change Standard Deviation .157	.098 percent signal change Standard Deviation .299
fMRI Brain Activations During Symptom Provocation Right amygdala Spider	.241 percent signal change Standard Deviation .157	.155 percent signal change Standard Deviation .347	.183 percent signal change Standard Deviation .336	.133 percent signal change Standard Deviation .230
fMRI Brain Activations During Symptom Provocation Right amygdala Butterfly	.082 percent signal change Standard Deviation .157	.181 percent signal change Standard Deviation .244	.203 percent signal change Standard Deviation .216	-.017 percent signal change Standard Deviation .273
fMRI Brain Activations During Symptom Provocation Left hippocampus Spider	.101 percent signal change Standard Deviation .222	.196 percent signal change Standard Deviation .217	.185 percent signal change Standard Deviation .184	.131 percent signal change Standard Deviation .206
fMRI Brain Activations During Symptom Provocation Left hippocampus Butterfly	.010 percent signal change Standard Deviation .180	.065 percent signal change Standard Deviation .112	.204 percent signal change Standard Deviation .170	.086 percent signal change Standard Deviation .158
fMRI Brain Activations During Symptom Provocation Right hippocampus Spider	.113 percent signal change Standard Deviation .315	.310 percent signal change Standard Deviation .224	.075 percent signal change Standard Deviation .193	.361 percent signal change Standard Deviation .347
fMRI Brain Activations During Symptom Provocation Right hippocampus Butterfly	.017 percent signal change Standard Deviation .103	.219 percent signal change Standard Deviation .203	.155 percent signal change Standard Deviation .118	.329 percent signal change Standard Deviation .283