Trial · NCT02797808
Effects of Sertraline on Brain Connectivity in Adolescents With OCD
NCT02797808, Phase 1, Phase 2, Completed, University of Minnesota; results first posted 2021-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Sertraline on Brain Connectivity in Adolescents With OCD. Trials, record NCT02797808. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02797808
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Sertraline on Brain Connectivity in Adolescents With OCD
- NCT number
- NCT02797808
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- OCD
- Interventions
- Sertraline, No Intervention
- First posted
- 2016-06-13
- Last updated
- 2021-01-05
- Results first posted
- 2021-01-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CY-BOCS Total Score at 12-weeks | 12 weeks | The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) a clinician-rated semi-structured instrument assessing OCD severity over the previous 7 days in children ages 6 to 17 years. Items are scored from 0 (none) to 4 (extreme) and total score ranges from 0 to 40 with higher scores indicating greater impairment. All 19 items are rated, but only items 1-10 are used to determine the total score. The total CY-BOCS score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. At this time, items 1A and 6A are not being used in the scoring. Items 17 (global severity) and 18 (global improvement) are adapted from the Clinical Global Impression Scale to provide measures of overall functional impairment associated with the presence of obsessive-compulsive symptoms. |
| Primary | Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | 12 weeks | Participants had whole brain fMRI at baseline \&12 weeks. Whole brain connectivity in 6 striatal ROIs was performed. Two-way mixed effects ANOVAs were performed with FEAT. Clusters were significant if p \<.0042 based on .05/(6 ROIs x 2 tests/ROI). Mean z-score was found for each time point in each subject's connectivity map in each significant cluster. Within-group paired-sample t tests examined RSFC change over time in these metrics for each group. To investigate group X time interactions from the 2-way ANOVA, we compared mean z-scores within each significant cluster at baseline \& 12 weeks. Resulting numbers represented striatal connectivity for each individual at each time point. Within group paired sample t-tests examined RSFC change over time for each group. Bonferroni correction was applied to alpha level (2-tailed, p\<0.5/6 =.0083) for multiple testing. We do not have an a priori hypothesis as to whether increase or decrease in RSFC is a better outcome. Unit of measure is z-score. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CY-BOCS Total Score at 12-weeks | 12 weeks | 2 additional participants with OCD and 1 Healthy Control were removed from this analysis due to motion effects in the neuroimaging data. | units on a scale | MEAN |
| PRIMARY | Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | 12 weeks | 2 additional participants with OCD and 1 Healthy Control were removed from this analysis due to motion effects in the neuroimaging data. | z score | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CY-BOCS Total Score at 12-weeks | Children With OCD | 14.1 | Standard Deviation 8.5 | units on a scale | |
| CY-BOCS Total Score at 12-weeks | Healthy Control Children | 0 | Standard Deviation 0 | units on a scale | |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Children With OCD | Connectivity z-scores for right putamen at baseline | 0.15 | Standard Deviation 1.04 | z score |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Healthy Control Children | Connectivity z-scores for right putamen at baseline | 1.44 | Standard Deviation 1.06 | z score |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Children With OCD | Connectivity z-scores for right putamen at 12 weeks | 1.89 | Standard Deviation 0.85 | z score |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Healthy Control Children | Connectivity z-scores for right putamen at 12 weeks | 0.60 | Standard Deviation 0.98 | z score |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Children With OCD | Connectivity z-scores for left putamen at baseline | 1.46 | Standard Deviation 1.14 | z score |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Healthy Control Children | Connectivity z-scores for left putamen at baseline | 2.41 | Standard Deviation 1.19 | z score |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Children With OCD | Connectivity z-scores for left putamen at week 12 | 3.03 | Standard Deviation 1.54 | z score |
| Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses | Healthy Control Children | Connectivity z-scores for left putamen at week 12 | 0.89 | Standard Deviation 0.99 | z score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Obsessive-compulsive Disorder | 23 | |
| Overall Study | STARTED | Healthy Controls | 18 | |
| Overall Study | COMPLETED | Obsessive-compulsive Disorder | 16 | |
| Overall Study | COMPLETED | Healthy Controls | 15 | |
| Overall Study | NOT COMPLETED | Obsessive-compulsive Disorder | 7 | |
| Overall Study | NOT COMPLETED | Healthy Controls | 3 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Medication Side Effect | General disorders | Obsessive-compulsive Disorder | 8 | 23 | 21 |
| other | Medication Side Effect | General disorders | Healthy Controls | 0 | 18 | 0 |
| serious | Seizure | Nervous system disorders | Obsessive-compulsive Disorder | 1 | 23 | 1 |
| serious | Seizure | Nervous system disorders | Healthy Controls | 0 | 18 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Obsessive-compulsive Disorder | 0 | 23 |
| Total, all-cause mortality | Healthy Controls | 0 | 18 |
| Total, other adverse events | Obsessive-compulsive Disorder | 8 | 23 |
| Total, other adverse events | Healthy Controls | 0 | 18 |
| Total, serious adverse events | Obsessive-compulsive Disorder | 1 | 23 |
| Total, serious adverse events | Healthy Controls | 0 | 18 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21MH101395 | Effects of Sertraline on Brain Connectivity in Adolescents with OCD | BERNSTEIN, GAIL A. | UNIVERSITY OF MINNESOTA | NATIONAL INSTITUTE OF MENTAL HEALTH | 2013 to 2014 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Obsessive-compulsive Disorder vs Healthy Controls: deaths from any cause | Trial comparisons |
| Obsessive-compulsive Disorder vs Healthy Controls: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02797808
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