Trial Outcomes & Findings for Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD (NCT NCT01695291)
NCT ID: NCT01695291
Last Updated: 2019-11-13
Results Overview
The Yale-Brown Obsessive Compulsive Scale, Child Version (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 YBOCS only in its use of simpler language. The total CYBOCS score ranges from 0 to 40, with higher scores indicating more severe symptomatology.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Change from Baseline at 4, 8, and 12 weeks
Results posted on
2019-11-13
Participant Flow
Participant milestones
| Measure |
Placebo
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
Placebo: A placebo pill will be administered twice a day (BID) for 12 weeks.
|
Minocycline Augmentation
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
21
|
|
Overall Study
COMPLETED
|
8
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
Placebo: A placebo pill will be administered BID for 12 weeks.
|
Minocycline Augmentation
n=21 Participants
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline at 4, 8, and 12 weeksPopulation: Due to the early-termination of some participants, not all completed the CYBOCS at Week 12
The Yale-Brown Obsessive Compulsive Scale, Child Version (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 YBOCS only in its use of simpler language. The total CYBOCS score ranges from 0 to 40, with higher scores indicating more severe symptomatology.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
Placebo: A placebo pill will be administered BID for 12 weeks.
|
Minocycline Augmentation
n=21 Participants
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)
Week 12
|
26.44 units on a scale
Standard Deviation 5.10
|
25.59 units on a scale
Standard Deviation 6.39
|
|
Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)
Baseline
|
28.20 units on a scale
Standard Deviation 3.79
|
29.0 units on a scale
Standard Deviation 3.49
|
|
Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)
Week 4
|
26.67 units on a scale
Standard Deviation 4.69
|
27.11 units on a scale
Standard Deviation 5.61
|
|
Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)
Week 8
|
25.33 units on a scale
Standard Deviation 5.22
|
25.47 units on a scale
Standard Deviation 5.77
|
SECONDARY outcome
Timeframe: Change from Baseline at 12 weeksPopulation: Due to the early-termination of some participants, not all completed MRS at Week 12
The change in striatal glutamate level will be assessed.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
Placebo: A placebo pill will be administered BID for 12 weeks.
|
Minocycline Augmentation
n=17 Participants
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
|
|---|---|---|
|
Striatal Glutamate Level Measured by Magnetic Resonance Spectroscopy (MRS).
Baseline
|
44.49 Arbitrary Units
Standard Deviation 6.76
|
43.96 Arbitrary Units
Standard Deviation 9.18
|
|
Striatal Glutamate Level Measured by Magnetic Resonance Spectroscopy (MRS).
Week 12
|
42.97 Arbitrary Units
Standard Deviation 8.25
|
39.35 Arbitrary Units
Standard Deviation 6.47
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Minocycline Augmentation
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
Placebo: A placebo pill will be administered BID for 12 weeks.
|
Minocycline Augmentation
n=21 participants at risk
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/10 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Drug Rash
|
0.00%
0/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Significant esophagitis
|
0.00%
0/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Psychiatric disorders
Worsening of OCD symptoms and an interrupted suicide attempt
|
0.00%
0/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
Placebo: A placebo pill will be administered BID for 12 weeks.
|
Minocycline Augmentation
n=21 participants at risk
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
|
|---|---|---|
|
Psychiatric disorders
Mood swings
|
30.0%
3/10 • 12 weeks
|
23.8%
5/21 • 12 weeks
|
|
Psychiatric disorders
Anxious, tense, uptight
|
20.0%
2/10 • 12 weeks
|
28.6%
6/21 • 12 weeks
|
|
Psychiatric disorders
Lack of self-control/impulsive
|
40.0%
4/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Psychiatric disorders
Trouble paying attention
|
30.0%
3/10 • 12 weeks
|
14.3%
3/21 • 12 weeks
|
|
Psychiatric disorders
Racing thoughts
|
40.0%
4/10 • 12 weeks
|
14.3%
3/21 • 12 weeks
|
|
Psychiatric disorders
Can't sit or stand still
|
40.0%
4/10 • 12 weeks
|
33.3%
7/21 • 12 weeks
|
|
Psychiatric disorders
Tired/fatigued
|
50.0%
5/10 • 12 weeks
|
23.8%
5/21 • 12 weeks
|
|
Psychiatric disorders
Sleep too much
|
20.0%
2/10 • 12 weeks
|
38.1%
8/21 • 12 weeks
|
|
Psychiatric disorders
Trouble falling or staying asleep
|
30.0%
3/10 • 12 weeks
|
19.0%
4/21 • 12 weeks
|
|
Metabolism and nutrition disorders
Lost weight
|
10.0%
1/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
General disorders
Dry mouth
|
10.0%
1/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
General disorders
More thirsty
|
10.0%
1/10 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
Metabolism and nutrition disorders
Feeling hungry
|
10.0%
1/10 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
Metabolism and nutrition disorders
Gained weight
|
10.0%
1/10 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscles weak
|
10.0%
1/10 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pimples or acne
|
10.0%
1/10 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Cardiac disorders
Heart racing or skipping beats
|
0.00%
0/10 • 12 weeks
|
14.3%
3/21 • 12 weeks
|
|
Gastrointestinal disorders
Stomach ache or cramps
|
10.0%
1/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
General disorders
Headache
|
10.0%
1/10 • 12 weeks
|
19.0%
4/21 • 12 weeks
|
|
Metabolism and nutrition disorders
Less hungry
|
0.00%
0/10 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
General disorders
Dizzy or light-headed
|
0.00%
0/10 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
Psychiatric disorders
Irritable or bad mood
|
20.0%
2/10 • 12 weeks
|
23.8%
5/21 • 12 weeks
|
|
Psychiatric disorders
Angry or hostile
|
10.0%
1/10 • 12 weeks
|
28.6%
6/21 • 12 weeks
|
|
Psychiatric disorders
Sad or low mood
|
40.0%
4/10 • 12 weeks
|
33.3%
7/21 • 12 weeks
|
|
Psychiatric disorders
Lack of interest
|
40.0%
4/10 • 12 weeks
|
28.6%
6/21 • 12 weeks
|
|
Psychiatric disorders
Feeling shutdown
|
40.0%
4/10 • 12 weeks
|
14.3%
3/21 • 12 weeks
|
Additional Information
Kelsey Hill, Research Coordinator
New York State Psychiatric Institute
Phone: 646-774-5793
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place