Clinical Study on Options of Medication Regimen in Treatment of Refractory Obsessive-Compulsive Disorder Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obsessive Compulsive Disorder
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: In phase I all the participants will be initially treated for sertraline for 12 weeks.non-remmitters will be randomly allocated to five treatment arms for another 12 weeks in phase II.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Selective Serotonin Reuptake Inhibitors(SSRIs) are the first line pharmacotherapy for Obsessive-Compulsive Disorder (OCD) according to APA?American Psychological Association?guideline. Nevertheless, a large proportion (40% or more) of patients response only partially or not at all to treatment with ...
Selective Serotonin Reuptake Inhibitors(SSRIs) are the first line pharmacotherapy for Obsessive-Compulsive Disorder (OCD) according to APA?American Psychological Association?guideline. Nevertheless, a large proportion (40% or more) of patients response only partially or not at all to treatment with a SSRI. On the basis of the existing sparse literature, pharmacotherapy options for treatment-refractory OCD outlined in current treatment guidelines include 1) treatment with higher than usual doses of an SSRI, 2) switch to a different SSRI, 3) switch to a different class of medication, 4) augmentation with a dopamine blocker, and 5) augmentation with a glutamatergic agent. This proposed Randomized Controlled Trial (RCT) study is a multi-center clinical study with a total of 13 centers that specialize in OCD patients. A randomized block design will be used in this study and all eligible participants accepted into this study will undergo an initial course of pharmacotherapy (phase I), and non-remmitters will be randomly allocated to five treatment arms (phase II). In phase I all participants will be treated for sertraline for 12 weeks.In phase II,The 5 arms will comprise 1) treatment with higher than usual doses of sertraline, 2) switch to fluvoxamine, 3) switch to venlafaxine, 4) augmentation with memantine, and 5) augmentation with aripiprazole. Clinicians and patients will know which treatment arm is being employed, but raters will be kept blind to treatment group.
Tracking Information
- NCT #
- NCT04539951
- Collaborators
- Guizhou Provincial People's Hospital
- The first specialized hospital of harbin
- First Affiliated Hospital of Jinan University
- West China Hospital
- Suzhou Psychiatric Hospital
- Nanjing Medical University
- Wuhan Mental Health Centre
- Seventh People's Hospital of Hangzhou
- The First Affiliated Hospital of Kunming Medical College
- Henan Mental Hospital
- General Hospital of Ningxia Medical University
- The First Affiliated Hospital of Nanchang University
- Investigators
- Principal Investigator: Zhen Wang, PhD,MD Shanghai Mental Health Center