Trial Outcomes & Findings for D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD (NCT NCT01172873)
NCT ID: NCT01172873
Last Updated: 2014-08-19
Results Overview
The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.
COMPLETED
NA
16 participants
baseline, visit 5, visit 10, follow-up visit
2014-08-19
Participant Flow
Recruitment was drawn from the broadest possible population with respect to gender and ethnic origin. Internal Review Board(IRB)-approved web/radio/newspaper ads \& flyers were used to recruit patients, as were physician and mental health practitioner referrals.
16 adolescents(12-17yrs) participated in the study. The initial 11 participants received 10 twice-weekly sessions of exposure and response prevention treatment (E/RP) as well as D-Cycloserine(DCS) 50mg at each session. The final 5 participants received 10 twice-weekly sessions of E/RP treatment alone during the active study period.
Participant milestones
| Measure |
D-cycloserine + E/RP
The first 11 participants received 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
|
E/RP Alone (no DCS Administration)
The final 5 participants enrolled in the study were assigned to a second treatment arm, to compare E/RP alone to E/RP with D-Cycloserine. These participants received 10 twice-weekly sessions of E/RP without D-Cycloserine. DCS was not administered to this group during the active study period.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
5
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
D-cycloserine + E/RP
The first 11 participants received 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
|
E/RP Alone (no DCS Administration)
The final 5 participants enrolled in the study were assigned to a second treatment arm, to compare E/RP alone to E/RP with D-Cycloserine. These participants received 10 twice-weekly sessions of E/RP without D-Cycloserine. DCS was not administered to this group during the active study period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD
Baseline characteristics by cohort
| Measure |
D-cycloserine + E/RP
n=11 Participants
Participants in this treatment arm received 10 twice-weekly sessions of E/RP treatment and were administered D-Cycloserine (DCS) immediately after every treatment visit.
|
E/RP Alone (no DCS Administration)
n=5 Participants
Five participants were enrolled in the second treatment arm as a comparison. The participants received 10 twice-weekly sessions of E/RP treatment alone.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.67 years
STANDARD_DEVIATION 1.32 • n=5 Participants
|
16.25 years
STANDARD_DEVIATION .96 • n=7 Participants
|
15.85 years
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, visit 5, visit 10, follow-up visitPopulation: Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.
The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.
Outcome measures
| Measure |
D-cycloserine + E/RP
n=9 Participants
Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
|
E/RP Alone (no DCS Administration)
n=5 Participants
Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
|
|---|---|---|
|
Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents
Baseline CYBOCS
|
26.56 units on a scale
Standard Deviation 3.91
|
27.25 units on a scale
Standard Deviation 3.6
|
|
Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents
Session 5 CYBOCS
|
22.44 units on a scale
Standard Deviation 5.17
|
19.8 units on a scale
Standard Deviation 7.26
|
|
Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents
Session 10 CYBOCS
|
19.67 units on a scale
Standard Deviation 8.77
|
17.2 units on a scale
Standard Deviation 11.55
|
|
Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents
Follow-Up CYBOCS
|
14.5 units on a scale
Standard Deviation 7.78
|
22 units on a scale
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: baseline, visit 5, visit 10, follow-up visitPopulation: Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.
Multidimensional Anxiety Scale for Children (MASC): This is a 39-item self-report that measures anxiety symptoms. It provides a total score, as well as 10 subscales, although only total scores will be analyzed. MASC scores range from 0-117, with higher scores representing greater severity of anxiety symptoms. The MASC and will be administered at baseline, session 5, session 10 and the follow-up visit for adolescents.
Outcome measures
| Measure |
D-cycloserine + E/RP
n=9 Participants
Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
|
E/RP Alone (no DCS Administration)
n=5 Participants
Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
|
|---|---|---|
|
Multidimensional Anxiety Scale for Children (MASC)
Baseline MASC
|
42.67 units on a scale
Standard Deviation 23.37
|
52.4 units on a scale
Standard Deviation 23.56
|
|
Multidimensional Anxiety Scale for Children (MASC)
Session 5 MASC
|
40.56 units on a scale
Standard Deviation 19.79
|
47.4 units on a scale
Standard Deviation 29.72
|
|
Multidimensional Anxiety Scale for Children (MASC)
Session 10 MASC
|
39.33 units on a scale
Standard Deviation 21.42
|
46.8 units on a scale
Standard Deviation 31.25
|
|
Multidimensional Anxiety Scale for Children (MASC)
Follow-Up MASC
|
NA units on a scale
Standard Deviation NA
Data were not collected at the follow-up visit for this treatment arm.
|
40.5 units on a scale
Standard Deviation 41.72
|
SECONDARY outcome
Timeframe: baseline, visit 5, visit 10, follow-up visitPopulation: Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures. Another was excluded because she was unable to provide reliable data on outcome measures.
Beck's Depression Inventory (BDI): This is a 21-item self report that measures depression symptoms and will be used for both adults and adolescents at baseline, session 5, session 10 and the follow-up visit. BDI-II scores range from 0-63, with higher scores representing greater severity of depression symptoms.
Outcome measures
| Measure |
D-cycloserine + E/RP
n=9 Participants
Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
|
E/RP Alone (no DCS Administration)
n=5 Participants
Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
|
|---|---|---|
|
Beck Depression Inventory (BDI)
Baseline BDI
|
13.11 units on a scale
Standard Deviation 12.41
|
12.5 units on a scale
Standard Deviation 0.71
|
|
Beck Depression Inventory (BDI)
Session 5 BDI
|
11.33 units on a scale
Standard Deviation 8.23
|
4.8 units on a scale
Standard Deviation 2.95
|
|
Beck Depression Inventory (BDI)
Session 10 BDI
|
9.67 units on a scale
Standard Deviation 7.21
|
4 units on a scale
Standard Deviation 2.35
|
|
Beck Depression Inventory (BDI)
Follow-Up BDI
|
NA units on a scale
Standard Deviation NA
Data were not collected at the follow-up visit for this treatment arm.
|
4.34 units on a scale
Standard Deviation 1.53
|
Adverse Events
D-cycloserine + E/RP
E/RP Alone (no DCS Administration)
Serious adverse events
| Measure |
D-cycloserine + E/RP
n=11 participants at risk
Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
|
E/RP Alone (no DCS Administration)
n=5 participants at risk
Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
|
|---|---|---|
|
Psychiatric disorders
Worsening of OCD symptoms
|
9.1%
1/11 • Number of events 1
|
0.00%
0/5
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/11
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
D-cycloserine + E/RP
n=11 participants at risk
Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
|
E/RP Alone (no DCS Administration)
n=5 participants at risk
Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
|
|---|---|---|
|
General disorders
Headache
|
27.3%
3/11 • Number of events 5
|
40.0%
2/5 • Number of events 3
|
|
Gastrointestinal disorders
GI distress
|
18.2%
2/11 • Number of events 4
|
40.0%
2/5 • Number of events 2
|
|
Psychiatric disorders
Exacerbation of anxiety
|
9.1%
1/11 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
Additional Information
Moira A. Rynn, M.D.
New York State Psychiatric Institute/Columbia University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place