The long-term safety and effect of memantine on PTSD: an open trial

JRCT ID: jRCTs031230484

Registered date:29/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: PTSD
• Date of first enrollment: 29/11/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Memantine

Outcome(s)

• Primary Outcome: Adverse events evaluated using the UKU Side Effect Rating Scale, blood tests, and blood pressure measurements.

Secondary Outcome

PDS-5 (PTSD Diagnostic Scale for DSM-5)
IES-R (Impact of Event Scale-Revised)
PTCI (Posttraumatic Cognitions Inventory)
DES (Dissociative Experiences Scale)
BDI-II (Beck Depression Inventory-II)
STAI (State-Trait Anxiety Inventory)
CGI (Clinical Global Impression)
RBANS (Repeatable Battery for the Assessment of Neuropsychological Status)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

1) PTSD patients who are over 18 years old and under 60 years old.
2) Patients who are receiving outpatient treatment at the National Center of Neurology and Psychiatry Hospital, collaborative research institutions, or other psychiatric medical institutions.
3) Patients who have the capacity to give informed consent themselves and from whom informed consent can be obtained.
4) Patients who wish to participate in this trial after successfully completing the fixed-dose administration and observation period in the exploratory randomized double-blind placebo-controlled comparison trial evaluating the efficacy and safety of memantine for PTSD conducted at our center, with Dr. Kim Yoshiharu as the principal investigator.

Exclude criteria

1) Patients with active schizophrenia or significant manic episodes in bipolar disorder.
2) Patients with strong suicidal ideation.
3) Patients with severe physical illnesses that could interfere with participation in the study, such as fractures.
4) Patients who are pregnant.
5) Patients who have the following physical illnesses, which are labeled as "cautionary use" in the package insert:
-Patients with a history of epilepsy or seizures
-Patients with impaired renal function
-Patients with factors that increase urine pH (renal tubular acidosis, severe urinary tract infection, etc.)
-Patients with severe liver dysfunction
6) Any other patients who the attending physician determines are not suitable for inclusion in the study.

Related Information

• Primary Sponsor: Zui Narita
• Source(s) of Monetary Support: National Center of Neurology and Psychiatry