Obsessive-Compulsive Disorder Clinical Trial
Official title:
Neurobiological Markers of Treatment Response for Anxiety and OCD
NCT number | NCT05663489 |
Other study ID # | BCBP-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 23, 2018 |
Est. completion date | December 11, 2027 |
Obsessive-compulsive disorder (OCD) and anxiety disorders are common and debilitating conditions which are often chronic when treatment is not provided. International guidelines recommend cognitive behavioral therapy (CBT) as the first-line treatment, and research has shown that CBT can be delivered over a concentrated period of time. The Bergen 4-Day Treatment (B4DT) is an exposure-based treatment which is delivered over four consecutive days. B4DT has been shown to induce rapid and long-lasting remission in around 70% of patients. This provides a platform for studying psychological and neurobiological changes associated with treatment response and non-response. The present study will investigate longitudinal changes in psychological measures and DNA methylation in patients who receive the B4DT, as well as a subset will also undergo multimodal brain imaging.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 11, 2027 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with obsessive-compulsive disorder, panic disorder or social anxiety disorder using DSM-5 criteria - Referred to National Clinic for 4-Day Treatment, Haukeland University Hospital, Bergen, Norway - Consented to participate in the "Kvalitetsregister for konsentrerte behandlingsformat" Exclusion Criteria: - Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse For MRI substudy: Inclusion Criteria: - For the healthy controls, no previous or current psychiatric disorders as detected by the Mini International Neuropsychiatric Interview (MINI) Exclusion Criteria: - MRI incompatibility (e.g. pregnancy, metal implants) |
Country | Name | City | State |
---|---|---|---|
Norway | Bergen Center for Brain Plasticity | Bergen | Vestland |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | Amsterdam UMC, location VUmc, Harvard Medical School (HMS and HSDM), Oslo University Hospital, University of Bergen, University of North Carolina, Chapel Hill, University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Symptom severity of obsessive-compulsive disorder | Before treatment | |
Primary | Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Symptom severity of obsessive-compulsive disorder | approximately 10 days after treatment | |
Primary | Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Symptom severity of obsessive-compulsive disorder | three months after treatment | |
Primary | Panic Disorder Severity Scale (PDSS) | Symptom severity of panic disorder | Before treatment | |
Primary | Panic Disorder Severity Scale (PDSS) | Symptom severity of panic disorder | approximately 10 days after treatment | |
Primary | Panic Disorder Severity Scale (PDSS) | Symptom severity of panic disorder | three months after treatment | |
Primary | Liebowitz Social Anxiety Scale (LSAS) | Symptom severity of social anxiety disorder | Before treatment | |
Primary | Liebowitz Social Anxiety Scale (LSAS) | Symptom severity of social anxiety disorder | approximately 10 days after treatment | |
Primary | Liebowitz Social Anxiety Scale (LSAS) | Symptom severity of social anxiety disorder | three months after treatment | |
Secondary | DNA Methylation | Samples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system | Before treatment | |
Secondary | DNA Methylation | Samples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system | approximately 10 days after treatment | |
Secondary | DNA Methylation | Samples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system | three months after treatment | |
Secondary | Magnetic Resonance Imaging | Brain functional and structural MRI will be collected for a subset of 100 OCD and 100 anxiety disorder patients as well as 50 healthy controls | Before treatment | |
Secondary | Magnetic Resonance Imaging | Brain functional and structural MRI will be collected for a subset of 100 OCD and 100 anxiety disorder patients as well as 50 healthy controls | approximately 10 days after treatment | |
Secondary | Magnetic Resonance Imaging | Brain functional and structural MRI will be collected for a subset of 100 OCD and 100 anxiety disorder patients as well as 50 healthy controls | three months after treatment |
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