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Trial record 53 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD

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ClinicalTrials.gov Identifier: NCT01172873
Recruitment Status : Completed
First Posted : July 30, 2010
Results First Posted : December 23, 2013
Last Update Posted : August 19, 2014
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obsessive Compulsive Disorder
Interventions Drug: D-cycloserine
Behavioral: Exposure and Response Prevention (EX/RP)
Enrollment 16
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 11 5
Completed 8 3
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             3             2
Arm/Group Title D-cycloserine + E/RP E/RP Alone (no DCS Administration) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 11 5 16
Hide Baseline Analysis Population Description
Sixteen participants ages 12-17 were enrolled in the study. All met criteria for a principal disorder of OCD. One participant consented but was then deemed ineligible to participate prior to baseline.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
<=18 years
11
 100.0%
5
 100.0%
16
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 5 participants 16 participants
15.67  (1.32) 16.25  (.96) 15.85  (1.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Female
5
  45.5%
2
  40.0%
7
  43.8%
Male
6
  54.5%
3
  60.0%
9
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 5 participants 16 participants
11 5 16
1.Primary Outcome
Title Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents
Hide Description 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.
Time Frame baseline, visit 5, visit 10, follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Hide Arm/Group Description:
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.
Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
Overall Number of Participants Analyzed 9 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline CYBOCS 26.56  (3.91) 27.25  (3.6)
Session 5 CYBOCS 22.44  (5.17) 19.8  (7.26)
Session 10 CYBOCS 19.67  (8.77) 17.2  (11.55)
Follow-Up CYBOCS 14.5  (7.78) 22  (3.61)
2.Secondary Outcome
Title Multidimensional Anxiety Scale for Children (MASC)
Hide Description 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.
Time Frame baseline, visit 5, visit 10, follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Hide Arm/Group Description:
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.
Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
Overall Number of Participants Analyzed 9 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline MASC 42.67  (23.37) 52.4  (23.56)
Session 5 MASC 40.56  (19.79) 47.4  (29.72)
Session 10 MASC 39.33  (21.42) 46.8  (31.25)
Follow-Up MASC NA [1]   (NA) 40.5  (41.72)
[1]
Data were not collected at the follow-up visit for this treatment arm.
3.Secondary Outcome
Title Beck Depression Inventory (BDI)
Hide Description 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.
Time Frame baseline, visit 5, visit 10, follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Hide Arm/Group Description:
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.
Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
Overall Number of Participants Analyzed 9 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline BDI 13.11  (12.41) 12.5  (0.71)
Session 5 BDI 11.33  (8.23) 4.8  (2.95)
Session 10 BDI 9.67  (7.21) 4  (2.35)
Follow-Up BDI NA [1]   (NA) 4.34  (1.53)
[1]
Data were not collected at the follow-up visit for this treatment arm.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Hide Arm/Group Description 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. Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
All-Cause Mortality
D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      1/5 (20.00%)    
Psychiatric disorders     
Worsening of OCD symptoms  [1]  1/11 (9.09%)  1 0/5 (0.00%)  0
Suicide attempt   0/11 (0.00%)  0 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
[1]
Worsening of OCD symptoms leading to inpatient hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
D-cycloserine + E/RP E/RP Alone (no DCS Administration)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/11 (54.55%)      2/5 (40.00%)    
Gastrointestinal disorders     
GI distress   2/11 (18.18%)  4 2/5 (40.00%)  2
General disorders     
Headache   3/11 (27.27%)  5 2/5 (40.00%)  3
Psychiatric disorders     
Exacerbation of anxiety   1/11 (9.09%)  1 1/5 (20.00%)  1
Indicates events were collected by systematic assessment

Due to small sample size of treatment groups, analyses comparing groups were not conducted. Therefore, we cannot conclude that findings were due to D-cycloserine (DCS) augmentation.

All participants received treatment from the same therapist.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Moira A. Rynn, M.D.
Organization: New York State Psychiatric Institute/Columbia University
Phone: 646-774-5805
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01172873     History of Changes
Other Study ID Numbers: #5828
First Submitted: April 20, 2009
First Posted: July 30, 2010
Results First Submitted: December 18, 2012
Results First Posted: December 23, 2013
Last Update Posted: August 19, 2014