NCT00980408

Brief Summary

The hippocampus is particularly laden with n-methyl-d-aspartate (NMDA) receptors, and is at the same time one of the most important sites in declarative memory. The rationale of this study is that the NMDA partial agonist D-Cycloserine will promote learning compared to a placebo. On the other hand, the NMDA receptor antagonist Memantine might lead to reduced memory. We believe that the influence of NMDA receptors on memory can be determined via acute co-activation of the NMDA receptors with Cycloserine® (King Pharmaceuticals Ltd, active ingredient: DCycloserin, dose: 250 mg) and Memantine (Axura®, Merz, active ingredient: Memantine, dose: 20 mg)on both a behavioral and functional (fMRI) level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3.2 years

First QC Date

September 18, 2009

Last Update Submit

December 2, 2014

Conditions

Healthy Individuals

Outcome Measures

Primary Outcomes (1)

  • fMRI during learning task

    once at drug administration

Study Arms (8)

Sugar pill, behavioral glutamic acid

PLACEBO COMPARATOR

Placebo condition for D-Cycloserine

Drug: Sugar pill

Sugar pill, fMRI, glutamic acid

PLACEBO COMPARATOR

Placebo condition for D-Cycloserine, fMRI

Drug: Sugar pill

Sugar pill, memantine, behavioral

PLACEBO COMPARATOR

Placebo condition Memantine, behavioral

Drug: Sugar pill

Sugar pill, memantine, fMRI

PLACEBO COMPARATOR

Placebo condition Memantine, fMRI

Drug: Sugar pill

D-Cycloserine behavioral

ACTIVE COMPARATOR
Drug: Glutamic Acid

D-Cycloserine, fMRI

ACTIVE COMPARATOR
Drug: Glutamic Acid

Memantine, behavioral

ACTIVE COMPARATOR
Drug: Memantine

Memantine, fMRI

ACTIVE COMPARATOR
Drug: Memantine

Interventions

Sugar pillDRUG

250 mg, one dose, 60 min prior

Also known as: Placebo condition for D-Cycloserine, behavioral study
Sugar pill, behavioral glutamic acid
Glutamic AcidDRUG

250 mg, one dose, 60 minutes prior

Also known as: D-Cycloserine, King Pharmaceuticals
D-Cycloserine behavioral
MemantineDRUG

20 mg, one dose, 8 hours prior

Also known as: Axura, Merz
Memantine, behavioral

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • German native language or native language level
  • Able to give written informed consent
  • right-handed

You may not qualify if:

  • inability to give written informed consent, underaged minors, contractually incapable persons, persons in legal custody
  • any psychiatric, neurological or internal illness
  • hematoporphyria (enzyme sickness)
  • intake of medication (except oral contraceptives)
  • simultaneous participation in other clinical studies
  • hypersensitivity to Memantine or other anti-dementia substances, or to D-Cycloserine
  • alcohol abuse
  • epilepsy
  • depression
  • serious anxiety or psychosis
  • serious kidney insufficiency
  • intake of Ethionamide or Isoniazide
  • pregnancy or women who are nursing
  • liver or kidney problems
  • intake of NMDA-antagonists, such as Amantadine, Ketamine, or Dextromethorphan
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forschungszentrum Juelich GmbH

Jülich, North Rhine-Westphalia, 52428, Germany

Location

Related Publications (1)

  • Onur OA, Schlaepfer TE, Kukolja J, Bauer A, Jeung H, Patin A, Otte DM, Shah NJ, Maier W, Kendrick KM, Fink GR, Hurlemann R. The N-methyl-D-aspartate receptor co-agonist D-cycloserine facilitates declarative learning and hippocampal activity in humans. Biol Psychiatry. 2010 Jun 15;67(12):1205-11. doi: 10.1016/j.biopsych.2010.01.022. Epub 2010 Mar 20.

    PMID: 20303474DERIVED

MeSH Terms

Interventions

SugarsCycloserineGlutamic AcidMemantine

Intervention Hierarchy (Ancestors)

CarbohydratesIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsGlutamatesAmino Acids, AcidicAmino Acids, DicarboxylicExcitatory Amino AcidsAmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

June 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

DE(1)