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| ID | Type | Description | Link |
|---|---|---|---|
| YG2013MS65 | Other Grant/Funding Number | Biomedical Engineering Cross Project of SJTU |
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| Name | Class |
|---|---|
| Shanghai Municipal Science and Technology Commission | OTHER_GOV |
| Shanghai Jiao Tong University School of Medicine | OTHER |
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The purpose of this study is to evaluate the efficiency of SSRIs（Selective Serotonin Reuptake Inhibitor） ,ERP（Exposure and Response Prevention） and the combination of the two therapies for OCD(Obsessive-Compulsive Disorder) patients ,at the same time, to find out the biological or psychological predictors of treatment response in Chinese population.
Although Selective Serotonin Reuptake Inhibitors(SSRIs) and Cognitive Behavior Therapy (CBT) including Exposure and Response Prevention(ERP) are two kinds of the first line treatments for OCD(Obsessive-Compulsive Disorder) according to APA（American Psychological Association）guideline. Both of the treatments are effective, but few research has been done to find out who are more responsive to one treatment than the other. The aim of our research is to evaluate the efficiency of SSRIs ,ERP and the combination of the two therapies for OCD patients ,at the same time, to find out the biological and psychological predictors of treatment response in Chinese population.
This is a randomized, single-blind, cross-over design study.Approximately 60 patients will be randomized to SSRIs or ERP group. Neuropsychological assessment and fMRI(Functional Magnetic Resonance Imaging） will be performed at baseline,during the treatment and at the end of the study. The research has two period. In the first period(before week 8) ,the patients will have monotherapy. In the second period(after week 8), rates of improvement based on the YBOCS(Yale-Brown Obsessive Compulsive Scale) scores will be assessed. The patient will be considered responsive to treatment when he or she has a reduction in YBOCS score ≥ 35% of the score at the baseline.If the patient is responsive to the treatment that he or she has received at the first 8 weeks,he or she will continue to follow the previous treatment strategy.If not,the patient will have a combination of SSRIs and ERP treatment for another 8 weeks. The follow-up period will last up to 6 months.The result of the study will improve our knowledge about the efficacy of the two first line treatments .Also,it will help us to find out the predictors of the outcome of the two different kinds of treatments.Strategy of clinical treatment of OCD will be more individualized in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective Serotonin Reuptake Inhibitor | Active Comparator | In this group,routine treatment strategies will be used for patients. Any one of the SSRIs including fluoxetine, citalopram, paroxetine, sertraline, fluvoxamine ,which are approved in the treatment of OCD by SFDA, may be used for patients who are randomized to this treatment arm. The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage. |
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| Exposure and Response Prevention | Active Comparator | Exposure and Response Prevention Structured protocol described by Foa et al., 2012 Patients will attend eight 1-h sessions,once a week. Benzodiazepine will be used when necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of Yale-Brown Obsessive-Compulsive Scale score | Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month | from baseline to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Beck Depression Inventory(BDI) score | Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month | from baseline to month 6 |
| The change of Beck Anxiety Inventory(BAI) score |
| Measure | Description | Time Frame |
|---|---|---|
| Stop Signal Task (SST) | a measure of behavioral response inhibition | from baseline to month 6 |
| fMRI(Functional Magnetic Resonance Imaging) - stop signal task | a measure of behavioral response inhibition |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhen Wang, Ph.D, M.D | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D020280 | Sertraline |
| D017374 | Paroxetine |
| D015283 | Citalopram |
| D003909 | Dexetimide |
| D016666 | Fluvoxamine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D015057 | 1-Naphthylamine |
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| Sertraline | Drug | The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage. |
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| Paroxetine | Drug | The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage. |
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| Citalopram | Drug | The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage. |
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| Fluvoxamine | Drug | The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage. |
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| Exposure and Response Prevention | Behavioral | 8 exposure and response prevention (ERP) sessions,once a week |
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Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month
| from baseline to month 6 |
| The change of Stress Perceived Questionnaire (PSS-10) score | Patients were assessed at 0 week(w),16w(0 month), 6 month | from baseline to month 6 |
| The change of Behavioral Inhibition/Behavioral Activation System Scales score | Patients were assessed at 0 week(w), 16w(0 month), 6 month | from baseline to month 6 |
| The change of Barratt Impulsiveness Scale 11 (BIS-11) score | Patients were assessed at 0 week(w), 16w(0 month), 6 month | from baseline to month 6 |
| The change of Obsessive Beliefs Questionnaire-44(OBQ-44) score | Patients were assessed at 0 week(w), 16w(0 month), 6 month | from baseline to month 6 |
| The NEO-Five Factor Inventory-Revised (NEO-FFI-R) | Patients were assessed at 0 week(w), | at baseline |
| The Early Trauma Inventory Self Report-Short Form(ETISR-SF) | Patients were assessed at 0 week(w) | at baseline |
| from baseline to month 6 |
| C Reaction Protein(CRP) | for safety considerations | from baseline to month 6 |
| Complete Blood Count | for safety considerations | from baseline to month 6 |
| Liver and Kidney Function | for safety considerations | from baseline to month 6 |
| Resting State Functional Magnetic Resonance Imaging | to quantify brain network | from baseline to month 6 |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010881 | Piperidones |
| D010091 | Oximes |
| D006898 | Hydroxylamines |