MedTrace Logo

Memantine for Refractory OCD Patients

NCT05015595 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-20

No results posted yet for this study

Summary

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.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

DRUG

Memantine Oral Tablet

Thirty-two-week double-blind up-titration treatment period (from T0 to T4): patients will be randomly assigned to one of two arms (Memantine or placebo) in a 1:1 ratio and will receive a daily administration of Memantine/placebo up to 20mg/day. Eight-week double-blind down-titration treatment period (from T4 to T5): At T4, the dose of Memantine/placebo will be reduced at 10mg/day due to safety reasons before the end of treatment (T5).

DRUG

Placebo

Thirty-two-week double-blind up-titration treatment period (from T0 to T4): patients will be randomly assigned to one of two arms (Memantine or placebo) in a 1:1 ratio and will receive a daily administration of Memantine/placebo up to 20mg/day. Eight-week double-blind down-titration treatment period (from T4 to T5): At T4, the dose of Memantine/placebo will be reduced at 10mg/day due to safety reasons before the end of treatment (T5).

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-10-31
Completion
2022-12-31

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05015595 on ClinicalTrials.gov