Trial Outcomes & Findings for 2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD (NCT NCT01404208)
NCT ID: NCT01404208
Last Updated: 2017-03-28
Results Overview
The CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
206 participants
Primary outcome timeframe
Change from Score at Randomization to Post Treatment
Results posted on
2017-03-28
Participant Flow
206 subjects were initially enrolled at MGH and USF. Of those, 32 were considered screen fails and 32 were not randomized either because they did not meet inclusion or exclusion criteria at randomization or because they withdrew consent or dropped out. Thus, 142 participants were randomized.
Participant milestones
| Measure |
D-Cycloserine
D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
|
Sugar Pill
Placebo: Sugar pill
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
72
|
|
Overall Study
COMPLETED
|
67
|
72
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
D-Cycloserine
D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
|
Sugar Pill
Placebo: Sugar pill
|
|---|---|---|
|
Overall Study
Discontinued
|
3
|
0
|
Baseline Characteristics
2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD
Baseline characteristics by cohort
| Measure |
D-Cycloserine
n=70 Participants
D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
|
Sugar Pill
n=72 Participants
Placebo: Sugar pill
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.67 Years
STANDARD_DEVIATION 2.94 • n=5 Participants
|
12.14 Years
STANDARD_DEVIATION 2.97 • n=7 Participants
|
12.40 Years
STANDARD_DEVIATION 2.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Score at Randomization to Post TreatmentThe CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity.
Outcome measures
| Measure |
D-Cycloserine
n=70 Participants
D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
|
Sugar Pill
n=72 Participants
Placebo: Sugar pill
|
|---|---|---|
|
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
|
-10.35 Change in score from randomization
Standard Deviation 7.72
|
-9.40 Change in score from randomization
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Change from Randomization Point to Post TreatmentThe Clinical Global Impression-Severity is a 7-point clinician rating of illness severity, with a score of 0 indicating no illness and a score of 6 indicating extremely severe symptoms. Because the secondary outcome was the change in score from randomization to post treatment, a more negative score indicates a greater reduction in symptom severity.
Outcome measures
| Measure |
D-Cycloserine
n=70 Participants
D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
|
Sugar Pill
n=72 Participants
Placebo: Sugar pill
|
|---|---|---|
|
Clinical Global Impression-Severity (CGI-Severity)
|
-1.39 Change in score from randomization
Standard Deviation 1.04
|
-1.2 Change in score from randomization
Standard Deviation .91
|
Adverse Events
D-Cycloserine
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-Cycloserine
n=70 participants at risk
D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
|
Sugar Pill
n=72 participants at risk
Placebo: Sugar pill
|
|---|---|---|
|
Nervous system disorders
Headache
|
55.7%
39/70
|
45.8%
33/72
|
|
Gastrointestinal disorders
Constipation
|
24.3%
17/70
|
12.5%
9/72
|
|
Nervous system disorders
Poor Memory
|
27.1%
19/70
|
11.1%
8/72
|
|
Gastrointestinal disorders
Nausea or Vomiting
|
32.9%
23/70
|
34.7%
25/72
|
|
General disorders
Feeling Drowsy or Sleepy
|
38.6%
27/70
|
38.9%
28/72
|
|
Eye disorders
Blurred Vision or Reading
|
11.4%
8/70
|
9.7%
7/72
|
|
Metabolism and nutrition disorders
Increased Appetite
|
24.3%
17/70
|
18.1%
13/72
|
|
Renal and urinary disorders
Difficulty Starting Urination
|
10.0%
7/70
|
6.9%
5/72
|
|
Nervous system disorders
Trouble Concentrating
|
32.9%
23/70
|
36.1%
26/72
|
|
Nervous system disorders
Nightmares
|
22.9%
16/70
|
15.3%
11/72
|
|
General disorders
Difficulty Sitting Still
|
27.1%
19/70
|
31.9%
23/72
|
|
Cardiac disorders
Heartbeat Irregular or Pounding
|
12.9%
9/70
|
9.7%
7/72
|
|
Gastrointestinal disorders
Diarrhea
|
22.9%
16/70
|
15.3%
11/72
|
|
Renal and urinary disorders
Frequent Need to Urinate
|
20.0%
14/70
|
5.6%
4/72
|
|
General disorders
Dry Mouth
|
24.3%
17/70
|
18.1%
13/72
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
24.3%
17/70
|
12.5%
9/72
|
|
General disorders
Tremors or Shakiness
|
15.7%
11/70
|
11.1%
8/72
|
|
Skin and subcutaneous tissue disorders
Skin Rash or Irritation
|
15.7%
11/70
|
18.1%
13/72
|
|
Ear and labyrinth disorders
Ringing in the Ears
|
12.9%
9/70
|
9.7%
7/72
|
|
Skin and subcutaneous tissue disorders
Sweating
|
17.1%
12/70
|
20.8%
15/72
|
|
Nervous system disorders
Faintness or Lightheadedness
|
25.7%
18/70
|
18.1%
13/72
|
|
General disorders
Poor Coordination
|
15.7%
11/70
|
12.5%
9/72
|
|
Musculoskeletal and connective tissue disorders
Stiffness in the Muscles
|
20.0%
14/70
|
13.9%
10/72
|
|
General disorders
Trouble Falling Asleep
|
44.3%
31/70
|
38.9%
28/72
|
|
General disorders
Feeling Tired
|
45.7%
32/70
|
40.3%
29/72
|
|
General disorders
Waking up During the Night
|
34.3%
24/70
|
23.6%
17/72
|
|
General disorders
Waking up too Early in the Morning
|
25.7%
18/70
|
23.6%
17/72
|
|
Nervous system disorders
Feeling Confused
|
20.0%
14/70
|
11.1%
8/72
|
|
Psychiatric disorders
Feeling Nervous or Sad
|
38.6%
27/70
|
29.2%
21/72
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
28.6%
20/70
|
18.1%
13/72
|
|
Ear and labyrinth disorders
Ear infection
|
2.9%
2/70
|
5.6%
4/72
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
5/70
|
9.7%
7/72
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
7.1%
5/70
|
5.6%
4/72
|
|
Gastrointestinal disorders
Stomach pain or discomfort
|
5.7%
4/70
|
12.5%
9/72
|
|
General disorders
Mouth or dental pain
|
0.00%
0/70
|
5.6%
4/72
|
|
General disorders
Fever
|
1.4%
1/70
|
8.3%
6/72
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
5/70
|
5.6%
4/72
|
|
Injury, poisoning and procedural complications
Body abrasions and bruising
|
5.7%
4/70
|
1.4%
1/72
|
|
Psychiatric disorders
Anxiety
|
10.0%
7/70
|
2.8%
2/72
|
|
Immune system disorders
Seasonal Allergies
|
1.4%
1/70
|
6.9%
5/72
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place