Clinical Study on Options of Medication Regimen in Treatment of Refractory Obsessive-Compulsive Disorder Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1600
  • sponsor
    Shanghai Mental Health Center
Updated on 27 January 2021
treatment regimen
fluvoxamine
sertraline
psychotherapy
memantine

Summary

This study includes a two-step clinical trial in order to assess the efficacy of several switching or augment strategies when initial treatment is ineffectiveand to provide strong evidence for clinical practice and international guidelines for Obsessive-Compulsive Disorder treatments.

Description

Selective Serotonin Reuptake Inhibitors(SSRIs) are the first line pharmacotherapy for Obsessive-Compulsive Disorder (OCD) according to APAAmerican Psychological Associationguideline. 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.

Details
Condition Obsessive-Compulsive Disorder, ANXIETY NEUROSIS, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders, obsessive compulsive disorder
Treatment Venlafaxine, Fluvoxamine, Sertraline 200 milligram(mg), Sertraline 300 milligram(mg), Augment with Memantine, Augment with Aripiprazole
Clinical Study IdentifierNCT04539951
SponsorShanghai Mental Health Center
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 16 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Obsessive-Compulsive Disorder or Anxiety Disorders (Pediatric) or ANXIETY NEUROSIS or Generalized Anxiety Disorder (GAD) or Generalized Anxiety Disord...?
Is your age between 18 yrs and 65 yrs?
Do you have any of these conditions: Anxiety Disorders or obsessive compulsive disorder or Anxiety Disorders (Pediatric) or Generalized Anxiety Disorder (GAD) or Obsessive-Compulsive Diso...?
Is your age between 18 yrs and 65 yrs?
Do you have any of these conditions: Obsessive-Compulsive Disorder or obsessive compulsive disorder or ANXIETY NEUROSIS or Anxiety Disorders (Pediatric) or Generalized Anxiety Disorder (G...?
Is your age between 18 yrs and 65 yrs?
Do you have any of these conditions: obsessive compulsive disorder or ANXIETY NEUROSIS or Generalized Anxiety Disorder (GAD) or Anxiety Disorders or Anxiety Disorders (Pediatric) or Obses...?
They
meet DSM-5 diagnostic criteria for OCD as the primary diagnosis
are in the age range from 18 to 65 years
have a score of at least 20 on Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
have never received medication for OCD, and have not received any form of psychotherapy for OCD in the past 1 month
have provided written informed consent

Exclusion Criteria

They
have met the DSM-5 diagnostic criteria for Schizophrenia Spectrum and Other Psychotic Disorders, or the Bipolar and Related Disorders
have a moderate or higher risk of suicide (9 on the Suicide Module in the Mini-International Neuropsychiatric Interview (MINI))
have substance use that is sufficiently severe to possibly impact negatively on treatment adherence in the past 1 year
have severe depression with Beck Depression Inventory-II (BDI-II) score of 29
have comorbid psychiatric or medical disorders that may impact negatively on adherence to or on the efficacy of medication (eg borderline personality disorder, CNS disorders)
are pregnant or lactating females
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