Clinical trial NCT04539951: Pragmatic Trial of Obsessive-compulsive Disorder
Official title: A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD
Conditions: Obsessive-Compulsive Disorder
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.
Interventions:
description: 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
name: Sertraline 200 milligram(mg)
type: Drug
description: 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).
name: Sertraline 300 milligram(mg)
type: Drug
description: 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.
name: Fluvoxamine
type: Drug
description: 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.
name: Venlafaxine
type: Drug
description: 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
name: Augment with Memantine
type: Drug
description: 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
name: Augment with Aripiprazole
type: Drug
Study arms:
design_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
design_group_title: serotonin treatment
design_group_type: Active Comparator
design_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.
design_group_title: sequenced treatment alternatives
design_group_type: Active Comparator
Sponsor: Shanghai Mental Health Center
Collaborators: Nanjing Medical University
Kunming Medical College No. 1 Attached Hospital
Henan Medical University
Guizhou Provincial People's Hospital
The First Affiliated Hospital of Jinan University
General Hospital of Ningxia Medical University
West China Hospital
The First Affiliated Hospital of Nanchang University
Drug name mappings:
name: 阿立哌唑
lang: CN
name: Aripiprazole
lang: EN
name: アリピプラゾール水和物
lang: JP
name: 马来酸氟伏沙明
lang: CN
name: Fluvoxamine Maleate
lang: EN
name: フルボキサミンマレイン酸塩
lang: JP
name: 盐酸舍曲林
lang: CN
name: Sertraline Hydrochloride
lang: EN
name: セルトラリン塩酸塩
lang: JP
name: 盐酸文拉法辛
lang: CN
name: Venlafaxine Hydrochloride
lang: EN
name: ベンラファキシン塩酸塩
lang: JP
name: DWJ-1458
lang: EN