A Phase 4 interventional study of Fluoxetine and Sertraline in Obsessive-Compulsive Disorder, Anxiety Disorders and Mental Disorders, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by Shanghai Mental Health Center · Phase 4, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 78 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
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.
Drug: Fluoxetine · Drug: Sertraline · Drug: Paroxetine · Drug: Citalopram · Drug: Fluvoxamine
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.
Behavioral: Exposure and Response Prevention
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Also known as: Prozac
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Also known as: Zoloft
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Also known as: Seroxat
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Also known as: Cipramil
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Also known as: Luvox
8 exposure and response prevention (ERP) sessions,once a week
Also known as: Exposure and Rituals Prevention
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
Time frame: from baseline to month 6
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
Time frame: from baseline to month 6
The change of Beck Anxiety Inventory(BAI) score
Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from baseline to month 6
The NEO-Five Factor Inventory-Revised (NEO-FFI-R)
Patients were assessed at 0 week(w),
Time frame: at baseline
The Early Trauma Inventory Self Report-Short Form(ETISR-SF)
Patients were assessed at 0 week(w)
Time frame: at baseline
Stop Signal Task (SST)
a measure of behavioral response inhibition
Time frame: from baseline to month 6
fMRI(Functional Magnetic Resonance Imaging) - stop signal task
a measure of behavioral response inhibition
Time frame: from baseline to month 6
C Reaction Protein(CRP)
for safety considerations
Time frame: from baseline to month 6
Complete Blood Count
for safety considerations
Time frame: from baseline to month 6
Liver and Kidney Function
for safety considerations
Time frame: from baseline to month 6
Resting State Functional Magnetic Resonance Imaging
to quantify brain network
Time frame: from baseline to month 6
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center