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Trial record 95 of 121 for:    CYCLOSERINE OR SEROMYCIN

The Influence of Glutamate on Memory in Humans

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ClinicalTrials.gov Identifier: NCT00980408
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

Tracking Information
First Submitted Date  ICMJE September 18, 2009
First Posted Date  ICMJE September 21, 2009
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE June 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
fMRI during learning task [ Time Frame: once at drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00980408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE The Influence of Glutamate on Memory in Humans
Official Title  ICMJE The NMDA Receptor Co-agonist D-cycloserine Accelerates Associative Learning in the Human Hippocampal CA Region
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Individuals
Intervention  ICMJE
  • Drug: Sugar pill
    250 mg, one dose, 60 min prior
    Other Name: Placebo condition for D-Cycloserine, behavioral study
  • Drug: Sugar pill
    250 mg, one dose, 60 min prior
    Other Name: Placebo condition for D-Cycloserine, fMRI
  • Drug: Sugar pill
    20 mg, one dose, 8 hours prior
    Other Name: Placebo condition Memantine, behavioral
  • Drug: Sugar pill
    20 mg, one dose, 8 hours prior
    Other Name: Placebo condition Memantine, fMRI
  • Drug: Glutamic Acid
    250 mg, one dose, 60 minutes prior
    Other Name: D-Cycloserine, King Pharmaceuticals
  • Drug: Memantine
    20 mg, one dose, 8 hours prior
    Other Name: Axura, Merz
Study Arms
  • Placebo Comparator: Sugar pill, behavioral glutamic acid
    Placebo condition for D-Cycloserine
    Intervention: Drug: Sugar pill
  • Placebo Comparator: Sugar pill, fMRI, glutamic acid
    Placebo condition for D-Cycloserine, fMRI
    Intervention: Drug: Sugar pill
  • Placebo Comparator: Sugar pill, memantine, behavioral
    Placebo condition Memantine, behavioral
    Intervention: Drug: Sugar pill
  • Placebo Comparator: Sugar pill, memantine, fMRI
    Placebo condition Memantine, fMRI
    Intervention: Drug: Sugar pill
  • Active Comparator: D-Cycloserine behavioral
    Intervention: Drug: Glutamic Acid
  • Active Comparator: D-Cycloserine, fMRI
    Intervention: Drug: Glutamic Acid
  • Active Comparator: Memantine, behavioral
    Intervention: Drug: Memantine
  • Active Comparator: Memantine, fMRI
    Intervention: Drug: Memantine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2009)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • vegetarians
  • stomach ulcer, if treated with medication
  • renal tubular acidosis
  • urinary infections (with proteus bacteria)
  • recent heart attack, heart failure, or uncontrolled high blood pressure
  • intake of L-Dopa, dopaminergic agonists, and anticholinergics
  • intake of barbiturates, spasmolytics, Phenytoin, Amantadine, oral coagulators, warfarin, HCT (Hydrochlorothiazide)
  • heart or cranial operations
  • pacemaker, medication pump (such as insulin pump), hearing aid, removable prosthodontics
  • metal in or on body (such as acupuncture needles, artificial limbs, stents, metal splints, clips, implanted electrodes, tattoos, or piercings)
  • claustrophobia
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00980408
Other Study ID Numbers  ICMJE RH999
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rene Hurlemann, University Hospital, Bonn
Study Sponsor  ICMJE University Hospital, Bonn
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bonn
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP