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Predicting treatment outcome in obsessive-compulsive disorder using neuroimaging biomarkers.


- candidate number26660
- NTR NumberNTR6575
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-feb-2017
- Secondary IDsNL57808.018.16, 2016_127 METC AMC
- Public TitlePredicting treatment outcome in obsessive-compulsive disorder using neuroimaging biomarkers.
- Scientific TitlePredicting treatment outcome in obsessive-compulsive disorder using neuroimaging biomarkers
- ACRONYMOCD-TBM
- hypothesisWe recently found that machine learning analysis of resting-state functional MRI obtained prior to treatment can reliably predict treatment outcome in depression (van Waarde et al. 2015). Here, we aim to apply these methods to OCD to develop a treatment selection biomarker that enables the allocation of patients to the treatment with the largest chance of success. In addition, we aim to determine the common and specific neural mechanisms underlying treatment efficacy.
- Healt Condition(s) or Problem(s) studiedObsessive-compulsive disorder (OCD)
- Inclusion criteriaPatients:
Diagnosis of obsessive compulsive disorder (OCD) according to the DSM-IV
18-70 years of age
Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
- Exclusion criteriaPatients:
Bipolar disorder, current or past psychosis, primary alcohol or drug abuse assessed by the MINI
Contraindication for MRI, such as metal implants, claustrophobia, and pregnancy
Major head trauma or neurological disease, current or in history
Adequate treatment of OCD with high dosed SSRI or CBT at the moment of screening or within 4 weeks before screening. Current treatment with tricyclic antidepressant or antipsychotic medication.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-nov-2016
- planned closingdate1-okt-2019
- Target number of participants120
- InterventionsThe subjects will be randomized to pharmacological treatment or cognitive behavioral therapy (CBT).
- Primary outcomeClassifier accuracy as the proportion of patients correctly classified as responder (sensitivity) and non-responder (specificity)
- Secondary outcomeDifferences in the proportion of responders between the randomized (first) and fMRI biomarker allocated (second) cohort
- TimepointsBefore treatment and 16 weeks after treatment.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Anouk van der Straten
- CONTACT for SCIENTIFIC QUERIESMD Anouk van der Straten
- Sponsor/Initiator Academic Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryObsessive-compulsive disorder (OCD) is a severely debilitating psychiatric disorder that is characterized by repetitive behaviour such as washing or cleaning, which may take up the entire day. First-line treatment for OCD consists of pharmacological treatment with selective serotonin reuptake inhibitors (SSRIs) or psychological treatment with cognitive-behavioral therapy (CBT) (van Balkom et al. 2013). Both these treatments are effective, but 40-60% of patients do not benefit sufficiently (Pallanti et al. 2002; Eddy et al. 2004). We recently found that machine learning analysis of resting-state functional MRI obtained prior to treatment can reliably predict treatment outcome in depression (van Waarde et al. 2015).
Here, we aim to apply these methods to OCD to develop a treatment selection biomarker that enables the allocation of patients to the treatment with the largest chance of success. In addition, we aim to determine the common and specific neural mechanisms underlying treatment efficacy. The analysis of CBT and SSRI-related changes at the level of brain areas and circuits will provide more perspective on the pathophysiology of OCD and the response to different treatments. Patients in the first cohort are randomized to SSRI or CBT to develop and validate a treatment selection fMRI biomarker for allocating OCD patients and to determine the divergent longitudinal effects on brain measures of treatment in patients with OCD. In the second cohort, patients will be allocated to SSRI or CBT based on fMRI biomarkers identified in the first cohort.
- Main changes (audit trail)
- RECORD8-feb-2017 - 5-aug-2017


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