An Open-Label Trial of Memantine for Cognitive Impairment in Patients With Post-Traumatic Stress Disorder

NCT02258828 | Completed Phase 4

• 1 other identifier: 00255
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty six veterans with PTSD and cognitive impairment received 16 weeks of memantine in an open label fashion. Cognition was assessed using the Spatial Span, Logical Memory I, and Letter-Number Sequencing subtests of the Wechsler Memory Scale III (Third edition) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS measures attention, language, visuospatial skills, and immediate and delayed memories. The Clinician Administered PTSD Scale (CAPS), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale (HAM-A), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and Sheehan Disability Scale (SDS) were used to assess improvement in PTSD symptoms, as secondary outcome measures.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• RBANS

  16 WEEKS

Study Arms (2)

Memantine

EXPERIMENTAL

Subjects initially received memantine 5 mg once daily, which was increased weekly by 5 mg/day in divided doses to a dose of 20 mg/day

Drug: Memantine

Placebo

PLACEBO COMPARATOR

Patient received matched placebo

Drug: Placebo

Interventions

Memantine DRUG

Subjects initially received memantine 5 mg once daily, which was increased weekly by 5 mg/day in divided doses to a dose of 20 mg/day

Also known as: Namenda

Memantine

Placebo DRUG

Matched placebo

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, men and women between 18 and 65 years of age, inclusive.
• Patients with diagnosis of Posttraumatic Stress Disorder (309.81) for at least 6 months, as determined by the Structured Clinical Interview for DSM-IV Axis 1 Disorders (SCID).
• Patients with a score of at least 1 standard deviation below the mean on the Spatial Span, Logical Memory I and Letter-Number Sequencing subtest's of the Wechsler Memory Scale III (Third edition).
• Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English,
• Patients, who signed the written informed consent given prior to entering any study procedure.
• Patients must be clinically stable on their medications for past three months

You may not qualify if:

• Patients with a concurrent DSM-IV Axis I or Axis II diagnosis in any of the following categories:
• Delirium, Dementia, Amnestic and other Cognitive disorders
• Mental Retardation
• Lifetime Schizophrenia and other Psychotic Disorders
• Lifetime Bipolar I Disorder
• Alcohol or Substance Dependence or Abuse (excluding nicotine) in one month prior to the Screening Visit
• Any other concurrent Axis I Disorder (including Major Depressive Disorder) must be secondary to the primary diagnosis of PTSD.
• Patients with a score of less than 1 standard deviation below the mean on the Spatial Span, Logical Memory I and Letter-Number Sequencing subtest's of the Wechsler Memory Scale III at the screening visit.
• Patients with a history of treatment with cholinesterase inhibitor drugs like donezepil, galantamine or rivigstamine.
• Patients with a history of intolerance or hypersensitivity to memantine.
• Patients with a history of seizures and traumatic head injury.
• Patients requiring concomitant treatment amantadine or dextromethorphan or carbonic anhydrase inhibitors.
• Patients who based on history or mental status examination have a significant risk of committing suicide.
• Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
• Patients with a positive urine drug screen, for drugs of abuse.

Sponsors & Collaborators

• Sriram Ramaswamy: lead
• Forest Laboratories: collaborator

Study Sites (1)

Omaha Veterans Affairs Medical Center

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Memantine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sriram Ramaswamy, MD

  Department of Veterans Affairs/NWIHCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: STAFF PSYCHIATRIST

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 8, 2014
• Study Start: July 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)