Pragmatic Trial of Obsessive-compulsive Disorder (Proceed)

Shanghai Mental Health Center

Status and phase: Enrolling; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Augment with Aripiprazole; Drug: Fluvoxamine; Drug: Augment with Memantine; Drug: Sertraline 200 milligram(mg); Drug: Sertraline 300 milligram(mg); Drug: Venlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT04539951

CRC2018ZD03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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1,600 participants in 2 patient groups

serotonin treatment

Active Comparator group

Description:

In experimental phase I, all recruited subjects provide written informed consent before any related procedures. Participants will receive sertraline, initially at 50mg/d, with a weekly 50mg/d further increase, to the maximum recommended dosage (200mg/d) or to the maximum tolerated dosage (less than 200mg/d). Patients will be on their maximum dose by week 4, so allowing an assessment of response at 12 weeks

Treatment:

Drug: Sertraline 200 milligram(mg)

sequenced treatment alternatives

Active Comparator group

Description:

If participants in In Experimental phase I do not achieve remission, they will be will be randomly assigned to the second-step treatment (Experimental phase II). The second-step therapy will consist of five treatment options including higher-than-usual-maximal dosage of sertraline, switching to fluvoxamine, switching to venlafaxine, augmentation with memantine, and augmentation with aripiprazole.

Treatment:

Drug: Venlafaxine

Drug: Sertraline 300 milligram(mg)

Drug: Augment with Memantine

Drug: Fluvoxamine

Drug: Augment with Aripiprazole