Obsessive-Compulsive DisorderPhase 4NCT03993535
Predicting Treatment Response in Patients With OCD
A Phase 4 study testing selective serotonin reuptake inhibitor in people with Obsessive-Compulsive Disorder, run by University of Sao Paulo at 4 sites in 4 countries.
Trial summary
This study consists of a naturalistic follow-up of subjects with Obsessive-Compulsive Disorder (OCD) that have participated in a global study investigating brain signatures of OCD funded by the National Institutes of Mental Health (RO1MH113250), with the following participant sites: the US (Columbia University, PI… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- selective serotonin reuptake inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 10 Oct 2018to 30 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Principal DSM-5 diagnosis of OCD
- Y-BOCS ≥ 16
- No psychotropic meds for the last 6 weeks, with the exception of PRN sleeping meds (e.g., zolpidem or trazodone up to 50 mg) and benzos, as long as not within the past week or during study participation
- No CBT/EXRP focused on OCD within the past 6 weeks
- Capable of providing informed consent
Who cannot join
- Lifetime diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, autism spectrum disorder with IQ < 80, Tourette Disorder
- Current chronic tic disorder (current = in the past 12 months)
- Current substance-related and addictive disorders, including nicotine (current = in the past 12 months)
- Current binge-eating disorder or bulimia (current = in the past 12 months)
- Acute risk of suicide
- Female who is pregnant
Show all 10Show fewer
- Major medical or neurological problems (including head injury with loss of consciousness) Presence of metallic devices or dental braces
- IQ < 80
- Cigarette use: more than 5 per day
- Alcohol use: more than 2 drinks per day for women and more than 3 drinks per day for men, Marijuana use: more than once per week
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Center for OCD and Related Disorders, New York State Psychiatric Institute/Columbia University Medical Center
New York, New York, 10032
Brazil1 site
Institute of Psychiatry - Hospital of Clinics - University of São Paulo
São Paulo, 05403-000
India1 site
OCD Clinic, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS)
Bangalore, 560029
South Africa1 site
Faculty of Medicine and Health Sciences, Department of Psychiatry, Stellenbosch University
Cape Town, 7505
About this study
Official title: Clinical, Neurocognitive and Neuroimaging Variables Associated With Response to Treatment in Patients With OCD
This study consists of a naturalistic follow-up of subjects with Obsessive-Compulsive Disorder (OCD) that have participated in a global study investigating brain signatures of OCD funded by the National Institutes of Mental Health (RO1MH113250), with the following participant sites: the US (Columbia University, PI: Helen Blair Simpson), Brazil (University of Sao Paulo, PIs: Euripedes Miguel and Roseli G Shavitt), India (National Institutes of Mental Health, PI: Janardhan Reddy), The Netherlands (VU Amsterdam Medical Center, PI: Odile van den Heuvel), and South Africa (University of Cape Town, PI: Dan Stein; Stellenbosch University, PI: Christine Lochner). In this cross-sectional study, two-hundred and fifty unmedicated subjects with OCD (50 per site) will be assessed for clinical, neurocognitive and neuroimaging data. After completion of this study, participants willing to receive evidence-based treatments for OCD will be treated with the available resources in each site and will be assessed for treatment response status periodically, with a final assessment after 1 year of naturalistic follow-up. At this point, we will investigate baseline clinical, neurocognitive and neuroimaging variables associated with the treatment response status.
Read the detailed description
This study aims to investigate clinical, neurocognitive and neuroimaging variables associated with response to conventional treatments in adults with OCD.
Study design:
- 0-52 weeks: open-label trial of a selective serotonin reuptake inhibitor (SSRI) (preferably sertraline - easily available in the public network, usually well tolerated) up to the maximum recommended or tolerated dose (e.g., titration: start with 50mg/day, then add 50mg/day per week up to 200mg/day, if sertraline); patients who prefer to be treated with cognitive-behavioral therapy (CBT) will be given this option whenever CBT is available.
- treatment will be delivered under naturalistic conditions, tailored according to the needs, preference, and availability. Subjects will be called up for follow-up assessments at 3, 6, 9 and 12 months after baseline assessments. The instruments to be used at follow-up are the YBOCS and CGI scales.
- Response criteria: the definitions of a recent international expert consensus will be adopted (Mataix-Cols. et al., 2016). A positive response will be considered as at least 35% reduction in baseline Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores plus a Clinical Global Impression-Improvement (CGI-I) rating of 1 ("very much improved") or 2 ("much improved"), lasting for at least one week. We will also rate the CGI - severity. Partial response will correspond to a greater than 25% but less than 35% reduction in Y-BOCS scores plus a CGI-I rating of at least 3 ("minimally improved"), lasting for at least one week.
Subjects:
- All participants assessed for clinical, neurocognitive and neuroimaging data in the global brain signatures study who are willing to receive evidence-based treatment for OCD.
Assessments:
- Baseline: clinical, neurocognitive and neuroimaging protocols.
- Clinical: interviewer-delivered and self-report measures to determine: socio-demographic data, past medical history, psychiatric family history, psychiatric diagnoses, OCD symptom dimensions, the severity of OCD, insight into OCD, sensory phenomena, the severity of depression and anxiety symptoms, severity of compulsive-impulsive behaviors, level of disability
- Neurocognitive: executive function, emotional regulation, memory
- Neuroimaging: structural MRI, resting-state functional MRI (rs-fMRI), Diffusion Tensor Imaging (DTI)
- Months 3, 6, 9 and 12: YBOCS checklist and past week severity; CGI - improvement subscale, relative to baseline; CGI - severity subscale; assessments can be in person or by phone, by the same independent evaluator at the different time points
- 1 year: treatment history form, YBOCS severity and checklist, Impulsive-Compulsive Behaviors Checklist (ICBC), Obsessive-Compulsive Inventory-Revised (OCI-R), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale (HAM-A), World Health Organization Disability Assessment Schedule (WHODAS), CGI.
Hypotheses (built from the literature): the following variables (as assessed at baseline) will show an association with response to treatment:
Clinical:
- duration of untreated illness (Alarcon et al., 1993; Ravizza et al., 1995; Stein et al., 2001);
- comorbidity: presence of comorbid social anxiety disorder (Carrasco et al., 1992), depressive disorders (Jakubovski et al., 2013); Post-Traumatic Stress Disorder (PTSD) (Shavitt et al., 2010);
- level of insight (Erzegovesi et al., 2001);
- symptom dimension: presence and severity of symmetry, contamination and hoarding dimensions (Alarcon et al., 1993; Ferrão et al., 2006; Mataix-Cols et al., 1999; Hazari et al., 2016)
Neurocognitive: decision making, verbal IQ (D'Alcante et al., 2012), verbal memory/learning (D'Alcante et al., 2012), inhibitory control and mental flexibility tasks (Flessner et al., 2010; Hazari et al., 2016).
Neuroimaging:
- Structural: brain volumes in the orbitofrontal cortex, anterior cingulate, striatum, dorsolateral and dorsomedial prefrontal cortex (Yun et al., 2015), insula (Yun et al., 2015), thalamus, hippocampus, pituitary gland (Atmaca et al., 2016), amygdala (Szeszko et al., 2004), and cerebellum.
II. Structural connectivity (Diffusion Tensor Imaging - DTI): fractional anisotropy measures in the corpus callosum, the internal capsule, white matter in the area superolateral to the right caudate, bilateral cingulum, superior longitudinal fasciculus, and inferior longitudinal fasciculus (Cannistraro et al., 2007; Szeszko wt al., 2005; Yoo et al., 2007; Garibotto et al., 2010).
III. Functional connectivity (rs-fMRI): patterns of activation and connectivity in frontal-striatal (central executive), parietal, occipital, cerebellar, and insula-limbic (saliency) networks (Shin et al., 2014; Bhikram et al., 2016; Nakao et al., 2005; Sanematsu et al., 2010) IV. Exploratory: multimodal analyses of prediction
Analyses plan: parametric and non-parametric tests will be employed as indicated.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- selective serotonin reuptake inhibitor
- Keywords
- obsessive-compulsive disorder, predictors, neuroimaging
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective serotonin reuptake inhibitorDrug
Also called CBT
open treatment based on patient preference and treatment availability
| Study group | Role | What they receive |
|---|---|---|
| SSRI or cognitive behavioral therapy | Other | selective serotonin reuptake inhibitors (fluoxetine, sertraline, citalopram, escitalopram, paroxetine or fluvoxamine) or cognitive-behavioral therapy, depending on availability and patient preference Receives: Drug: selective serotonin reuptake inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
response status
severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale. The final score of this scale is a sum of 10 items, ranging from 0 to 40. The higher the score, the more severe the clinical picture. The ten items refer to ten questions, five regarding obsessions and five regarding compulsions. The questions assess time, distress, interference, resistance and control over the symptoms. Each question can be rated from 0 (= none) to 4 (most severe).
Measured: 12 months
level of improvement
measured by the Clinical Global Impression Scale - severity and improvement subscales. The severity subscale can be rated from 1 to 7, a higher score corresponding to more severe symptoms. The improvement subscale can also be rated from 1 to 7, a greater score corresponding to lesser improvement. Scores are given individually to each subscale, in absolute numbers (1 to 7)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start10 Oct 2018
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12-month naturalistic follow-up of open treatment with evidence-based pharmacologic agents (SSRIs) or cognitive-behavioral therapy (CBT) for OCD
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch, Columbia University, National Institute of Mental Health and Neuro Sciences, India, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Roseli Gedanke Shavitt, University of Sao Paulo
- Investigators
- Roseli G Shavitt, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993535
- Sponsor's protocol ID
- 68743617800000068
- Status last verified
- Feb 2024
- First submitted
- 13 Jun 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alarcon RD, Libb JW, Spitler D. A predictive study of obsessive-compulsive disorder response to clomipramine. J Clin Psychopharmacol. 1993 Jun;13(3):210-3.
PubMed 8354737Atmaca M, Mermi O, Yildirim H, Gurok MG. Orbito-frontal cortex and thalamus volumes in obsessive-compulsive disorder before and after pharmacotherapy. Brain Imaging Behav. 2016 Sep;10(3):669-74. doi: 10.1007/s11682-015-9426-0.
PubMed 26311393Baer L, Jenike MA, Black DW, Treece C, Rosenfeld R, Greist J. Effect of axis II diagnoses on treatment outcome with clomipramine in 55 patients with obsessive-compulsive disorder. Arch Gen Psychiatry. 1992 Nov;49(11):862-6. doi: 10.1001/archpsyc.1992.01820110026003.
PubMed 1444723Bhikram TP, Farb NA, Ravindran LN, Papadopoulos YG, Conn DK, Pollock BG, Ravindran AV. The Effect of Intravenous Citalopram on the Neural Substrates of Obsessive-Compulsive Disorder. J Neuropsychiatry Clin Neurosci. 2016 Summer;28(3):243-7. doi: 10.1176/appi.neuropsych.15090213. Epub 2016 Mar 28.
PubMed 27019066Cannistraro PA, Makris N, Howard JD, Wedig MM, Hodge SM, Wilhelm S, Kennedy DN, Rauch SL. A diffusion tensor imaging study of white matter in obsessive-compulsive disorder. Depress Anxiety. 2007;24(6):440-6. doi: 10.1002/da.20246.
PubMed 17096398Carrasco JL, Hollander E, Schneier FR, Liebowitz MR. Treatment outcome of obsessive compulsive disorder with comorbid social phobia. J Clin Psychiatry. 1992 Nov;53(11):387-91.
PubMed 1459968D'Alcante CC, Diniz JB, Fossaluza V, Batistuzzo MC, Lopes AC, Shavitt RG, Deckersbach T, Malloy-Diniz L, Miguel EC, Hoexter MQ. Neuropsychological predictors of response to randomized treatment in obsessive-compulsive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Dec 3;39(2):310-7. doi: 10.1016/j.pnpbp.2012.07.002. Epub 2012 Jul 10.
PubMed 22789662Erzegovesi S, Cavallini MC, Cavedini P, Diaferia G, Locatelli M, Bellodi L. Clinical predictors of drug response in obsessive-compulsive disorder. J Clin Psychopharmacol. 2001 Oct;21(5):488-92. doi: 10.1097/00004714-200110000-00006.
PubMed 11593074Flessner CA, Allgair A, Garcia A, Freeman J, Sapyta J, Franklin ME, Foa E, March J. The impact of neuropsychological functioning on treatment outcome in pediatric obsessive-compulsive disorder. Depress Anxiety. 2010 Apr;27(4):365-71. doi: 10.1002/da.20626.
PubMed 19842168Garibotto V, Scifo P, Gorini A, Alonso CR, Brambati S, Bellodi L, Perani D. Disorganization of anatomical connectivity in obsessive compulsive disorder: a multi-parameter diffusion tensor imaging study in a subpopulation of patients. Neurobiol Dis. 2010 Feb;37(2):468-76. doi: 10.1016/j.nbd.2009.11.003. Epub 2009 Nov 11.
PubMed 19913616Hazari N, Narayanaswamy JC, Arumugham SS. Predictors of response to serotonin reuptake inhibitors in obsessive-compulsive disorder. Expert Rev Neurother. 2016 Oct;16(10):1175-91. doi: 10.1080/14737175.2016.1199960. Epub 2016 Jun 30.
PubMed 27282021Jakubovski E, Diniz JB, Valerio C, Fossaluza V, Belotto-Silva C, Gorenstein C, Miguel E, Shavitt RG. Clinical predictors of long-term outcome in obsessive-compulsive disorder. Depress Anxiety. 2013 Aug;30(8):763-72. doi: 10.1002/da.22013. Epub 2012 Oct 25.
PubMed 23109056Jenike MA, Baer L, Minichiello WE, Schwartz CE, Carey RJ Jr. Concomitant obsessive-compulsive disorder and schizotypal personality disorder. Am J Psychiatry. 1986 Apr;143(4):530-2. doi: 10.1176/ajp.143.4.530.
PubMed 3953896Mataix-Cols D, Rauch SL, Manzo PA, Jenike MA, Baer L. Use of factor-analyzed symptom dimensions to predict outcome with serotonin reuptake inhibitors and placebo in the treatment of obsessive-compulsive disorder. Am J Psychiatry. 1999 Sep;156(9):1409-16. doi: 10.1176/ajp.156.9.1409.
PubMed 10484953Mataix-Cols D, Fernandez de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016 Feb;15(1):80-1. doi: 10.1002/wps.20299. No abstract available.
PubMed 26833615
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Neurocognitive and Neuroimaging Variables Associated With Response to Treatment in Patients With OCD
- ClinicalTrials.gov ID
- NCT03993535
- Acronym / sponsor ID
- 68743617800000068
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, predictors, neuroimaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Stellenbosch, Columbia University, National Institute of Mental Health and Neuro Sciences, India, Amsterdam UMC, location VUmc
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consists of a naturalistic follow-up of subjects with Obsessive-Compulsive Disorder (OCD) that have participated in a global study investigating brain signatures of OCD funded by the National Institutes of Mental Health (RO1MH113250), with the following participant sites: the US (Columbia University, PI: Helen Blair Simpson), Brazil (University of Sao Paulo, PIs: Euripedes Miguel and Roseli G Shavitt), India (National Institutes of Mental Health, PI: Janardhan Reddy), The Netherlands (VU Amsterdam Medical Center, PI: Odile van den Heuvel), and South Africa (University of Cape Town, PI: Dan Stein; Stellenbosch University, PI: Christine Lochner). In this cross-sectional study, two-hundred and fifty unmedicated subjects with OCD (50 per site) will be assessed for clinical, neurocognitive and neuroimaging data. After completion of this study, participants willing to receive evidence-based treatments for OCD will be treated with the available resources in each site and will be assessed for treatment response status periodically, with a final assessment after 1 year of naturalistic follow-up. At this point, we will investigate baseline clinical, neurocognitive and neuroimaging variables associated with the treatment response status.
Detailed description
This study aims to investigate clinical, neurocognitive and neuroimaging variables associated with response to conventional treatments in adults with OCD.
Study design:
- 0-52 weeks: open-label trial of a selective serotonin reuptake inhibitor (SSRI) (preferably sertraline - easily available in the public network, usually well tolerated) up to the maximum recommended or tolerated dose (e.g., titration: start with 50mg/day, then add 50mg/day per week up to 200mg/day, if sertraline); patients who prefer to be treated with cognitive-behavioral therapy (CBT) will be given this option whenever CBT is available.
- treatment will be delivered under naturalistic conditions, tailored according to the needs, preference, and availability. Subjects will be called up for follow-up assessments at 3, 6, 9 and 12 months after baseline assessments. The instruments to be used at follow-up are the YBOCS and CGI scales.
- Response criteria: the definitions of a recent international expert consensus will be adopted (Mataix-Cols. et al., 2016). A positive response will be considered as at least 35% reduction in baseline Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores plus a Clinical Global Impression-Improvement (CGI-I) rating of 1 ("very much improved") or 2 ("much improved"), lasting for at least one week. We will also rate the CGI - severity. Partial response will correspond to a greater than 25% but less than 35% reduction in Y-BOCS scores plus a CGI-I rating of at least 3 ("minimally improved"), lasting for at least one week.
Subjects:
- All participants assessed for clinical, neurocognitive and neuroimaging data in the global brain signatures study who are willing to receive evidence-based treatment for OCD.
Assessments:
- Baseline: clinical, neurocognitive and neuroimaging protocols.
- Clinical: interviewer-delivered and self-report measures to determine: socio-demographic data, past medical history, psychiatric family history, psychiatric diagnoses, OCD symptom dimensions, the severity of OCD, insight into OCD, sensory phenomena, the severity of depression and anxiety symptoms, severity of compulsive-impulsive behaviors, level of disability
- Neurocognitive: executive function, emotional regulation, memory
- Neuroimaging: structural MRI, resting-state functional MRI (rs-fMRI), Diffusion Tensor Imaging (DTI)
- Months 3, 6, 9 and 12: YBOCS checklist and past week severity; CGI - improvement subscale, relative to baseline; CGI - severity subscale; assessments can be in person or by phone, by the same independent evaluator at the different time points
- 1 year: treatment history form, YBOCS severity and checklist, Impulsive-Compulsive Behaviors Checklist (ICBC), Obsessive-Compulsive Inventory-Revised (OCI-R), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale (HAM-A), World Health Organization Disability Assessment Schedule (WHODAS), CGI.
Hypotheses (built from the literature): the following variables (as assessed at baseline) will show an association with response to treatment:
Clinical:
- duration of untreated illness (Alarcon et al., 1993; Ravizza et al., 1995; Stein et al., 2001);
- comorbidity: presence of comorbid social anxiety disorder (Carrasco et al., 1992), depressive disorders (Jakubovski et al., 2013); Post-Traumatic Stress Disorder (PTSD) (Shavitt et al., 2010);
- level of insight (Erzegovesi et al., 2001);
- symptom dimension: presence and severity of symmetry, contamination and hoarding dimensions (Alarcon et al., 1993; Ferrão et al., 2006; Mataix-Cols et al., 1999; Hazari et al., 2016)
Neurocognitive: decision making, verbal IQ (D'Alcante et al., 2012), verbal memory/learning (D'Alcante et al., 2012), inhibitory control and mental flexibility tasks (Flessner et al., 2010; Hazari et al., 2016).
Neuroimaging:
- Structural: brain volumes in the orbitofrontal cortex, anterior cingulate, striatum, dorsolateral and dorsomedial prefrontal cortex (Yun et al., 2015), insula (Yun et al., 2015), thalamus, hippocampus, pituitary gland (Atmaca et al., 2016), amygdala (Szeszko et al., 2004), and cerebellum.
II. Structural connectivity (Diffusion Tensor Imaging - DTI): fractional anisotropy measures in the corpus callosum, the internal capsule, white matter in the area superolateral to the right caudate, bilateral cingulum, superior longitudinal fasciculus, and inferior longitudinal fasciculus (Cannistraro et al., 2007; Szeszko wt al., 2005; Yoo et al., 2007; Garibotto et al., 2010).
III. Functional connectivity (rs-fMRI): patterns of activation and connectivity in frontal-striatal (central executive), parietal, occipital, cerebellar, and insula-limbic (saliency) networks (Shin et al., 2014; Bhikram et al., 2016; Nakao et al., 2005; Sanematsu et al., 2010) IV. Exploratory: multimodal analyses of prediction
Analyses plan: parametric and non-parametric tests will be employed as indicated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12-month naturalistic follow-up of open treatment with evidence-based pharmacologic agents (SSRIs) or cognitive-behavioral therapy (CBT) for OCD
| Arm | Type | Receives |
|---|---|---|
| SSRI or cognitive behavioral therapy | Other | Drug: selective serotonin reuptake inhibitorselective serotonin reuptake inhibitors (fluoxetine, sertraline, citalopram, escitalopram, paroxetine or fluvoxamine) or cognitive-behavioral therapy, depending on availability and patient preference |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Principal DSM-5 diagnosis of OCD
- Y-BOCS ≥ 16
- No psychotropic meds for the last 6 weeks, with the exception of PRN sleeping meds (e.g., zolpidem or trazodone up to 50 mg) and benzos, as long as not within the past week or during study participation
- No CBT/EXRP focused on OCD within the past 6 weeks
- Capable of providing informed consent
Key exclusion criteria (10 listed)
- Lifetime diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, autism spectrum disorder with IQ < 80, Tourette Disorder
- Current chronic tic disorder (current = in the past 12 months)
- Current substance-related and addictive disorders, including nicotine (current = in the past 12 months)
- Current binge-eating disorder or bulimia (current = in the past 12 months)
- Acute risk of suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective serotonin reuptake inhibitorAlso: CBTopen treatment based on patient preference and treatment availability | Drug | SSRI or cognitive behavioral therapy |
Primary outcome
response status
Time frame: 12 months
severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale. The final score of this scale is a sum of 10 items, ranging from 0 to 40. The higher the score, the more severe the clinical picture. The ten items refer to ten questions, five regarding obsessions and five regarding compulsions. The questions assess time, distress, interference, resistance and control over the symptoms. Each question can be rated from 0 (= none) to 4 (most severe).
level of improvement
Time frame: 12 months
measured by the Clinical Global Impression Scale - severity and improvement subscales. The severity subscale can be rated from 1 to 7, a higher score corresponding to more severe symptoms. The improvement subscale can also be rated from 1 to 7, a greater score corresponding to lesser improvement. Scores are given individually to each subscale, in absolute numbers (1 to 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 8354737Alarcon RD, Libb JW, Spitler D. A predictive study of obsessive-compulsive disorder response to clomipramine. J Clin Psychopharmacol. 1993 Jun;13(3):210-3.
- Background: PubMed 26311393Atmaca M, Mermi O, Yildirim H, Gurok MG. Orbito-frontal cortex and thalamus volumes in obsessive-compulsive disorder before and after pharmacotherapy. Brain Imaging Behav. 2016 Sep;10(3):669-74. doi: 10.1007/s11682-015-9426-0.
- Background: PubMed 1444723Baer L, Jenike MA, Black DW, Treece C, Rosenfeld R, Greist J. Effect of axis II diagnoses on treatment outcome with clomipramine in 55 patients with obsessive-compulsive disorder. Arch Gen Psychiatry. 1992 Nov;49(11):862-6. doi: 10.1001/archpsyc.1992.01820110026003.
- Background: PubMed 27019066Bhikram TP, Farb NA, Ravindran LN, Papadopoulos YG, Conn DK, Pollock BG, Ravindran AV. The Effect of Intravenous Citalopram on the Neural Substrates of Obsessive-Compulsive Disorder. J Neuropsychiatry Clin Neurosci. 2016 Summer;28(3):243-7. doi: 10.1176/appi.neuropsych.15090213. Epub 2016 Mar 28.
- Background: PubMed 17096398Cannistraro PA, Makris N, Howard JD, Wedig MM, Hodge SM, Wilhelm S, Kennedy DN, Rauch SL. A diffusion tensor imaging study of white matter in obsessive-compulsive disorder. Depress Anxiety. 2007;24(6):440-6. doi: 10.1002/da.20246.
- Background: PubMed 1459968Carrasco JL, Hollander E, Schneier FR, Liebowitz MR. Treatment outcome of obsessive compulsive disorder with comorbid social phobia. J Clin Psychiatry. 1992 Nov;53(11):387-91.
- Background: PubMed 22789662D'Alcante CC, Diniz JB, Fossaluza V, Batistuzzo MC, Lopes AC, Shavitt RG, Deckersbach T, Malloy-Diniz L, Miguel EC, Hoexter MQ. Neuropsychological predictors of response to randomized treatment in obsessive-compulsive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Dec 3;39(2):310-7. doi: 10.1016/j.pnpbp.2012.07.002. Epub 2012 Jul 10.
- Background: PubMed 11593074Erzegovesi S, Cavallini MC, Cavedini P, Diaferia G, Locatelli M, Bellodi L. Clinical predictors of drug response in obsessive-compulsive disorder. J Clin Psychopharmacol. 2001 Oct;21(5):488-92. doi: 10.1097/00004714-200110000-00006.
- Background: PubMed 19842168Flessner CA, Allgair A, Garcia A, Freeman J, Sapyta J, Franklin ME, Foa E, March J. The impact of neuropsychological functioning on treatment outcome in pediatric obsessive-compulsive disorder. Depress Anxiety. 2010 Apr;27(4):365-71. doi: 10.1002/da.20626.
- Background: PubMed 19913616Garibotto V, Scifo P, Gorini A, Alonso CR, Brambati S, Bellodi L, Perani D. Disorganization of anatomical connectivity in obsessive compulsive disorder: a multi-parameter diffusion tensor imaging study in a subpopulation of patients. Neurobiol Dis. 2010 Feb;37(2):468-76. doi: 10.1016/j.nbd.2009.11.003. Epub 2009 Nov 11.
- Background: PubMed 27282021Hazari N, Narayanaswamy JC, Arumugham SS. Predictors of response to serotonin reuptake inhibitors in obsessive-compulsive disorder. Expert Rev Neurother. 2016 Oct;16(10):1175-91. doi: 10.1080/14737175.2016.1199960. Epub 2016 Jun 30.
- Background: PubMed 23109056Jakubovski E, Diniz JB, Valerio C, Fossaluza V, Belotto-Silva C, Gorenstein C, Miguel E, Shavitt RG. Clinical predictors of long-term outcome in obsessive-compulsive disorder. Depress Anxiety. 2013 Aug;30(8):763-72. doi: 10.1002/da.22013. Epub 2012 Oct 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roseli G Shavitt, MD, PhD principal investigator
University of Sao Paulo
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing selective serotonin reuptake inhibitor in people with Obsessive-Compulsive Disorder, run by University of Sao Paulo at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Brazil, India, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response status (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993535, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.