Trial · NCT01813019
Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy
NCT01813019, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2016-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy. Trials, record NCT01813019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01813019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy
- NCT number
- NCT01813019
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Patient Diagnosed With OCD and Resistant to SSRI Treatment, Failed SSRI Over 12 Weeks at Appropriate Doses
- Interventions
- AFQ056, Placebo
- First posted
- 2013-03-18
- Last updated
- 2017-01-02
- Results first posted
- 2016-07-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing). | baseline, week 17 | The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 ("no symptoms") to 4 ("extreme symptoms") and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity: 0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change. |
| Secondary | Y-BOCS Reduction in Total Score From Baseline | 16 weeks | If a subject demonstrates at least 25% reduction in total Y-BOCS from Baseline then they will be classed as a responder whereas if a subject has a reduction in Y-BOCS of less than 25% then they will be categorized as a nonresponder. |
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 | Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing). | baseline, week 17 | Pharmacodynamics (PD) analysis set only participants that were analyzed at baseline and Week 17. Positive change from baseline indicates a decrease in symptom severity | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Y-BOCS Reduction in Total Score From Baseline | 16 weeks | The study was terminated due to an interim analysis of the primary efficacy outcome. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective therefore secondary objective was not measured. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing). | Placebo | -8.0 | Standard Error 1.78 | Scores on a scale | |
| Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing). | AFQ056 | -6.9 | Standard Error 1.75 | Scores on a scale |
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 | Placebo | 24 | |
| Overall Study | STARTED | AFQ056 | 26 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | COMPLETED | AFQ056 | 20 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | AFQ056 | 6 |
Source ClinicalTrials.gov
Adverse events44
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 | Bradycardia | Cardiac disorders | Placebo | 2 | 24 | |
| other | Bradycardia | Cardiac disorders | AFQ056 | 0 | 26 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 24 | |
| other | Vertigo | Ear and labyrinth disorders | AFQ056 | 2 | 26 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 24 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AFQ056 | 2 | 26 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 24 | |
| other | Dyspepsia | Gastrointestinal disorders | AFQ056 | 2 | 26 | |
| other | Fatigue | General disorders | Placebo | 1 | 24 | |
| other | Fatigue | General disorders | AFQ056 | 2 | 26 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | AFQ056 | ||
| Total, other adverse events | Placebo | 15 | 24 |
| Total, other adverse events | AFQ056 | 18 | 26 |
| Total, serious adverse events | Placebo | 2 | 24 |
| Total, serious adverse events | AFQ056 | 1 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28044255 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AFQ056 vs Placebo: serious adverse events |
Source 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/NCT01813019
GET https://conductscience.org/api/trials/v1/NCT01813019/events?page=2