Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia

NCT01555697 | Completed Phase 1 Results DMC

• 1 other identifier: NIMH-R34-MH093453-NS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive training is moderately effective at reducing symptoms and improving life function in schizophrenia patients. The present application develops a strategy for increasing the effectiveness of cognitive training through the use of pro-cognitive medications. Specific biomarkers will be studied that identify patients most sensitive to these pro-cognitive medications, to test the feasibility of using these biomarkers in a large clinical trial of medication-enhanced cognitive training in schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; prepulse inhibition; neurocognition; working memory; memantine; MATRICS Consensus Cognitive Battery

Outcome Measures

Primary Outcomes (1)

• Prepulse Inhibition

  Prepulse inhibition of the startle reflex is the automatic reduction in startle magnitude (assessed here by EMG of orbicularis oculi) when a startling stimulus (here a 40 ms 118 dB(A) noise burst; "PULSE") is preceded (here 10 - 120 msec) by a weak stimulus (here a 20 msec burst 16 dB over background "PREPULSE"). A %PPI metric is calculated based on the relative startle magnitude on (PREPULSE + PULSE) trials vs. PULSE alone trials. Possible maximal inhibition is 100%; there is no maximal "negative" value of inhibition. There is no clear "advantage" or "disadvantage" for lower or higher %PPI values, though on average, schizophrenia patients demonstrate lower % values compared to matched healthy subjects.

  approx 45 minutes

Secondary Outcomes (1)

• MATRICS

  approx 1 hour

Study Arms (4)

Memantine/high

ACTIVE COMPARATOR

memantine 20 mg

Drug: Memantine

Placebo/high

PLACEBO COMPARATOR

placebo comparator for memantine 20 mg

Drug: Placebo

Memantine/low

ACTIVE COMPARATOR

memantine 10 mg

Drug: Memantine

Placebo/low

PLACEBO COMPARATOR

placebo comparator for memantine 10 mg

Drug: Placebo

Interventions

Memantine DRUG

Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.

Also known as: Namenda

Memantine/high; Memantine/low

Placebo DRUG

Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.

Placebo/high; Placebo/low

Eligibility Criteria

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

You may qualify if:

• A diagnosis of schizophrenia or schizoaffective disorder - depressed type

You may not qualify if:

• Age range,
• Current alcohol or drug abuse

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Neal Swerdlow, M.D., Ph.D.
• Organization: UC San Diego

nswerdlow@health.ucsd.edu

619-543-6270

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: July 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 4, 2022
• Results First Posted: August 10, 2020

Record last verified: 2022-09

Locations

US (1)