NCT05015595: MemaROCD

Memantine for Refractory OCD Patients

Status unknown Phase 3 Last updated 20 August 2021

What this trial tests

Phase 3 trial testing Memantine Oral Tablet in Obsessive-Compulsive Disorder in 20 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
31 October 2022

31 December 2022

Quick facts

Lead sponsor	University of Roma La Sapienza
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	1 September 2021
Primary completion	31 October 2022
Estimated completion	31 December 2022

Drugs / interventions tested

• Memantine Oral Tablet — full drug profile →
• Placebo

Conditions studied

• Obsessive-Compulsive Disorder — all drugs for Obsessive-Compulsive Disorder →

Sponsor

University of Roma La Sapienza

Who can join

Adults 18 to 55, any sex, with Obsessive-Compulsive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obsessive-compulsive disorder (OCD) is a psychiatric syndrome characterized by unwanted and repetitive thoughts and repeated ritualistic compulsions aimed to decrease the distress. Symptoms can cause severe distress and functional impairment. OCD affects 2-3% of the population and is ranked within the ten leading neuropsychiatric causes of disability. Dysfunction of the cortico-striatal-thalamo-cortical circuitry (CSTC) has been implicated in OCD, including altered brain activation and connectivity. A complex dysregulation of glutamatergic signaling within the cortico-striatal circuitry has been proposed in OCD. Data obtained by several studies are suggesting of a reduced glutamatergic concentrations in the anterior cingulate cortex, combined with overactivity of glutamatergic signaling in the striatum and orbitofrontal cortex. A growing number of RCTs have assessed the utility of different glutamate-modulating drugs as an augmentation or monotherapy in OCD, including refractory patients. However, there are relevant variations in between studies in terms of treatment-resistance, comorbidity, age and gender of the patients. At the present time four RCTs are available on the efficacy of memantine as an augmentation medication for refractory OCD patients. Investigators intend to conduce a double-blind, randomized, parallel group, placebo-controlled, monocentric trial to assess the efficacy and safety of memantine, a low-to-moderate affinity noncompetitive NMDAR antagonist that is currently approved for the treatment of Alzheimer disease, as an augmentative agent to a SSRI in treatment of patients affected by severe refractory OCD. Study design consists of four distinct periods (52 weeks) including memantine titration, neuropsychological assessment and follow-up.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Memantine for Refractory Obsessive-Compulsive Disorder: Protocol for a Pragmatic, Double-blind, Randomized, Parallel-Group, Placebo-Controlled, Monocenter Trial.
   Maraone A, Trebbastoni A, Di Vita A, D'Antonio F, et al · · 2023 · cited 1× · PMID 37166948 · DOI 10.2196/39223