Trial Outcomes & Findings for Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS (NCT NCT04015596)
NCT ID: NCT04015596
Last Updated: 2026-05-20
Results Overview
The CY-BOCS-II is a clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsion, each ranging from 0-25, with a higher score indicating more symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 50, that is used to measure overall OCD symptom severity.
TERMINATED
PHASE4
2 participants
Pre- to Post-8 week treatment
2026-05-20
Participant Flow
Pre-screening information was collected prior to randomization to determine study eligibility. If the participant met all eligibility requirements, and if the result of their laboratory tests for kidney, clotting, FOBT, and liver function were within normal limits, they were randomized to active treatment or placebo conditions.
Participant milestones
| Measure |
Intervention
Participants receive Naproxen Sodium.
|
Placebo
Participants receive placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Pre- to Post-8 week treatmentPopulation: Results are not posted due to potential risk to confidentiality given low enrollment.
The CY-BOCS-II is a clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsion, each ranging from 0-25, with a higher score indicating more symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 50, that is used to measure overall OCD symptom severity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre- to Post-8 week treatmentPopulation: Results are not posted due to potential risk to confidentiality given low enrollment.
The CY-BOCS-I is a clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsion, each ranging from 0-20, with a higher score indicating more symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 40, that is used to measure overall OCD symptom severity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre- to Post-8 week treatmentPopulation: Results are not posted due to potential risk to confidentiality given low enrollment.
C reactive protein (CRP, mg/L) will be obtained from pre- and post-blood draws and will be compared between groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre- to Post-8 week treatmentPopulation: Results are not posted due to potential risk to confidentiality given low enrollment.
Erythrocyte sedimentation rate (ESR, mm/h) will be obtained from pre- and post-blood draws and will be compared between groups.
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place