Memantine for Refractory OCD Patients

NCT05015595 | Unknown Phase 3

• 1 other identifier: RM11916B7477A1B6
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Obsessive-Compulsive Disorder; Refractory; Memantine; Augmentation medication

Outcome Measures

Primary Outcomes (1)

• Improvement of OCD symptoms will be intended as a rate of more then 1/3 on the Y-BOCS total score.

  The investigators will evaluate the improvement of symptoms through a decrease of OCD, intended as a rate of more then 1/3 on the Y-BOCS total score.

  From the week number 5 to the week number 52

Secondary Outcomes (2)

• Evaluate the minimum effective dose of memantine

  From the week number 5 to the week number 46

• Evaluate the effects after drug withdrawal through follow up

  From the week number 5 to the week number 46

Other Outcomes (9)

• Improvement at the WAIS-IV.

  from the week number 5 to the week number 52

• Improvement at the Trial Making Test.

  from the week number 5 to the week number 52

• Improvement at the Digit and Corsi Span.

  from the week number 5 to the week number 52

Study Arms (2)

Memantine

ACTIVE COMPARATOR

For thirty-two-week double-blind up-titration treatment period (from T0 to T4) each patient will receive a daily administration of Memantine up to 20mg/day. Subsequently, each patient will undergone to a double-blind down-titration treatment period for eight-weeks (from T4 to T5). At T4, the dose of Memantine will be reduced at 10mg/day due to safety reasons before the end of treatment (T5).

Drug: Memantine Oral Tablet

Placebo

PLACEBO COMPARATOR

For thirty-two-week double-blind up-titration treatment period (from T0 to T4) each patient will receive a daily administration of placebo 20 mg/day. Subsequently, each patient will undergone to a double-blind down-titration treatment period for eight-weeks (from T4 to T5). At T4, the dose of Placebo will be reduced at 10mg/day, following the study protocol, before the end of treatment (T5).

Drug: Placebo

Interventions

Memantine Oral Tablet DRUG

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).

Memantine

Placebo DRUG

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).

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis by a psychiatrist of current OCD according to the DSM 5
• patients in therapy with a stable SSRI for at least three weeks prior
• written informed consent.

You may not qualify if:

• Substance dependence
• IQ \<70
• comorbid psychiatric disorders
• female pregnant or breast-feeding or intend to become pregnant during the period of the study
• concomitant treatments (rTMS, CBT, other glutamate-modulating drugs)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (25)

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  PMID: 37166948 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Massimo Pasquini, MD

CONTACT

+39 06 49914121; massimo.pasquini@uniroma1.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD, MD

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 20, 2021
• Study Start: September 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share