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Obsessive-Compulsive DisorderPhase 2ProceedNCT04539951

Pragmatic Trial of Obsessive-compulsive Disorder

A Phase 2 study testing Sertraline 200 milligram(mg), Sertraline 300 milligram(mg) and Fluvoxamine in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Sertraline 200 milligram(mg), Sertraline 300 milligram(mg) and Fluvoxamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
1 siteChina
Study dates
22 Sep 2020to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhen Wang, PhD,MD contact

862134773516

wangzhen@smhc.org.cn

China1 site, 1 recruiting

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

    Zhen Wang, Ph.D, M.D, 862134773516, wangzhen@smhc.org.cn

    Zhen Wang, Ph.D, M.D

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Sertraline 200 milligram(mg), Sertraline 300 milligram(mg), Fluvoxamine, Venlafaxine, Augment with Memantine
Keywords
Obsessive-Compulsive Disorder, Pharmacotherapy, Treatment-naïve, Alternatives
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • FluvoxamineDrug

    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.

  • VenlafaxineDrug

    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 MemantineDrug

    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 AripiprazoleDrug

    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

Study groups in NCT04539951
Study groupRoleWhat they receive
serotonin treatmentActive comparatorIn 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
Receives: Drug: Sertraline 200 milligram(mg)
sequenced treatment alternativesActive comparatorIf 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.
Receives: Drug: Sertraline 300 milligram(mg); Drug: Fluvoxamine; Drug: Venlafaxine; Drug: Augment with Memantine; Drug: Augment with Aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: from baseline to 12 weeks, and 12 weeks to month 6.

Secondary outcomes (6)

  1. The Clinical Global Impression (CGI)

    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.

    Measured: from 2 weeks to 12 weeks, and 12 weeks to month 6.

  2. Beck Anxiety Inventory (BAI)

    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.

    Measured: from baseline to 12 weeks, and 12 weeks to month 6.

  3. Beck Depression Inventory(BDI)

    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.

    Measured: from baseline to 12 weeks, and 12 weeks to month 6.

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

    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.

    Measured: from baseline to 12 weeks, and 12 weeks to month 6.

  5. Treatment Emergent Symptom Scale (TESS)

    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.

    Measured: from 2 weeks to 12 weeks , and 12 weeks to month 6.

  6. Tolerability scale

    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.

    Measured: from 2 weeks to 12 weeks , and 12 weeks to month 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2020
  2. Study start22 Sep 2020
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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 blind
Who is masked
Outcomes assessor
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04539951
Sponsor's protocol ID
CRC2018ZD03
Acronym
Proceed
Status last verified
May 2025
First submitted
27 Aug 2020
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35651818

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sertraline 200 milligram(mg), Sertraline 300 milligram(mg) and Fluvoxamine in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhen Wang, PhD,MD (862134773516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) (time frame: from baseline to 12 weeks, and 12 weeks to month 6.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04539951, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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