Clinical trial NCT04539951: Pragmatic Trial of Obsessive-compulsive Disorder
Official title: A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
Pharmacotherapy
Treatment-naïve
Alternatives
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: The first specialized hospital of harbin
name: Guizhou Provincial People's Hospital
name: First Affiliated Hospital of Jinan University
name: West China Hospital
name: Suzhou Psychiatric Hospital
name: Nanjing Medical University
name: Wuhan Mental Health Centre
name: Seventh People's Hospital of Hangzhou
name: First Affiliated Hospital of Kunming Medical University
name: General Hospital of Ningxia Medical University
name: The First Affiliated Hospital of Nanchang University
name: The Second Affiliated Hospital of Xinxiang Medical University
First posted: 2020-09-07
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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

Detailed 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 a SSRI. On the basis of the existing sparse literature, several pharmacotherapy options for OCD patients who do not respond, or who respond but do not remit, have been outlined in current treatment guidelines. These 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. There is a need for additional data, particularly real-world data, on how best to choose between these options.

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 with 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.

Eligibility criteria: Inclusion criteria: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 (BDI) 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.

Primary outcomes:
measure: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
timeFrame: from baseline to 12 weeks, and 12 weeks to month 6.
Secondary outcomes:
measure: The Clinical Global Impression (CGI)
timeFrame: from 2 weeks to 12 weeks, and 12 weeks to month 6.
measure: Beck Anxiety Inventory (BAI)
timeFrame: from baseline to 12 weeks, and 12 weeks to month 6.
measure: Beck Depression Inventory(BDI)
timeFrame: from baseline to 12 weeks, and 12 weeks to month 6.
measure: Obsessive-Compulsive Inventory-Revised(OCI-R)
timeFrame: from baseline to 12 weeks, and 12 weeks to month 6.
measure: Treatment Emergent Symptom Scale (TESS)
timeFrame: from 2 weeks to 12 weeks , and 12 weeks to month 6.
measure: Tolerability scale
timeFrame: from 2 weeks to 12 weeks , and 12 weeks to month 6.
Other outcomes:
measure: Complete Blood Count
timeFrame: baseline
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang P, Gu W, Gao J, Wang C, Fang J, Hu M, Xiang H, Li B, Liu N, Tang W, Wang X, Jia Y, Li Y, Cheng Y, Tang Z, Simpson HB, Stein DJ, Wang Z. Protocol for a Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD (PROCEED). Front Psychiatry. 2022 May 16;13:822976. doi: 10.3389/fpsyt.2022.822976. eCollection 2022.