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NCT Number: NCT04539951

Pragmatic Trial of Obsessive-compulsive Disorder

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Zhen Wang, Ph.D, M.D

CONTACT

[email protected]

862134773516

Zhen Wang, Ph.D, M.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline 200 milligram(mg)

Drug

All included 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

Sertraline 300 milligram(mg)

Drug

In experimental phase II, the patients in this group will remain on sertraline (higher dosage): where sertraline 200mg has been tolerated, dosage will be increased by 50mg fortnightly to a maximal dose of 300mg/d or to the maximum tolerable dose (less than 300mg/d).

Fluvoxamine

Drug

Fluvoxamine will be initiated at a dose of 50mg/d, increasing quickly to a maximal dose of 300mg/d or the maximum tolerated dose by week 4.

Venlafaxine

Drug

venlafaxine will be initiated at 75mg/d, increasingly weekly by 75mg/day, to a maximal dose of 300 mg/d or the maximum tolerated dose.

Augment with Memantine

Drug

Sertraline will be augmented with memantine initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d (10mg twice daily) or the maximum tolerated dose

Augment with Aripiprazole

Drug

Sertraline will be augmented with aripiprazole, initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d or the maximum tolerated dose

Primary outcomes

  1. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

    Time frame: from baseline to 12 weeks, and 12 weeks to month 6.

    Y-BOCS is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), with separate subtotals for severity of obsessions and compulsions.Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.

Secondary outcomes

  1. The Clinical Global Impression (CGI)

    Time frame: from 2 weeks to 12 weeks, and 12 weeks to month 6.

    The Clinical Global Impression (CGI; National Institute of Mental Health) is a clinician-rated scale to assess treatment response in patients with mental disorders. The scale contains three items: Severity of Illness; Global Improvement; Efficacy Index. It requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline measurement. Patients will be assessed at week 2, week 4, week 8, week 12, week 16, week 20, month 6.

  2. Beck Anxiety Inventory (BAI)

    Time frame: from baseline to 12 weeks, and 12 weeks to month 6.

    BAI is a 21-item inventory which identifies anxiety symptoms and quantifies their intensity. Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.

  3. Beck Depression Inventory(BDI)

    Time frame: from baseline to 12 weeks, and 12 weeks to month 6.

    BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.

  4. Obsessive-Compulsive Inventory-Revised(OCI-R)

    Time frame: from baseline to 12 weeks, and 12 weeks to month 6.

    OCI-R is the measure of election for the assessment of obsessive-compulsive behaviors, given its validity and the short time that its administration requires. Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.

  5. Treatment Emergent Symptom Scale (TESS)

    Time frame: from 2 weeks to 12 weeks , and 12 weeks to month 6.

    The Treatment Emergent Symptom Scale (TESS) is used to record side effects. The side effects are assessed on a five-point scale ranging from 0 ("no side effects") to 4 ("severe side effects"). Patients will be assessed at week 2, week 4, week 8, week 12, week 16, week 20, month 6.

  6. Tolerability scale

    Time frame: from 2 weeks to 12 weeks , and 12 weeks to month 6.

    The tolerability of treatment will be defined as side effect discontinuation in this study. as defined by the proportion of patients who discontinued treatment due to adverse events during the study.Patients will be assessed at week 2, week 4, week 8, week 12, week 16, week 20, month 6.

Other outcomes

  1. Complete Blood Count

    Time frame: baseline

    for safety considerations

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Wang, PhD,MD

CONTACT

[email protected]

862134773516

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • First Affiliated Hospital of Jinan University
  • First Affiliated Hospital of Kunming Medical University
  • General Hospital of Ningxia Medical University
  • Guizhou Provincial People's Hospital
  • Nanjing Medical University
  • Seventh People's Hospital of Hangzhou
  • Suzhou Psychiatric Hospital
  • The First Affiliated Hospital of Nanchang University
  • The Second Affiliated Hospital of Xinxiang Medical University
  • The first specialized hospital of harbin
  • West China Hospital
  • Wuhan Mental Health Centre

Registry information

Official study title

A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD

Acronym: Proceed

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Sep 7, 2020
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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