Trial document




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  DRKS00005268

Trial Description

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Title

A pharmacological provocation of the glutamatergic and the cholinergic system. A fMRI study.

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Trial Acronym

NEWMDES pharmaco fmri

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URL of the Trial

[---]*

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Brief Summary in Lay Language

• To test and characterize the sensitivity of the NEWMEDS WP4 fMRI battery (emotional, cognitive and reward tasks) to pharmacological modulation in healthy subjects following a single intravenous administration of ketamine, scopolamine or placebo.
• To seek differential compound effects on the different task responses.
• To explore differential compounds effects on functional brain connectivity at rest.
• To contribute toward a reference data set against which novel compounds can then be profiled.

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Brief Summary in Scientific Language

Kognition and memory are modulted by acetycholine and glutamate. This is of importance in psychiatry, where these neurotransmitters
play a role in schizophrenia and alzheimer. To better understand the pathophysiology and disease mechanisms, we developde a standardized fmri test battery. By modulation the glutamatergic system and the cholinergic system with a pharmacologic probe in healthy volunteers we want to study these effects in our testbattery.

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Organizational Data

  •   DRKS00005268
  •   2013/09/12
  •   [---]*
  •   yes
  •   Approved
  •   2012-600N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy Volunteers
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Interventions/Observational Groups

  •   40 min ketamine infusion 0.5 mg /kg body weight
  •   0.4 µg scopolamine infusion per kg bodyweight for 15 min
  •   waterinfusion 40 min (placebo)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Other
  •   Other
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

fmri BOLD response one hour after infusion

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/09/01
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

healthy volunteers

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Exclusion Criteria

pregnany, psychiatric or neurologic disease, contraindications for scopolamine or ketamine, glaucoma, tachyarrhythmia, ileus, myasthenia gravis, hyperthyreosis, renal insufficiency, liver function disorder, history of heart disease

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Addresses

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    • ZI Mannheim
    • Mr.  Prof  Andreas  Meyer-Lindenberg 
    • J5
    • 68159  Mannheim
    • Germany
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    • ZI Mannheim
    • Mr.  Dr.  Oliver  Grimm 
    • J5
    • 68159  Mannheim
    • Germany
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    • ZI Mannheim
    • Mr.  Dr.  Oliver  Grimm 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • NEWMEDS c/o CIMH Mannheim
    • 68159   Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/19
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Trial Publications, Results and other Documents

  •   Cao H, Plichta MM, Schafer A, Haddad L, Grimm O, Schneider M, Esslinger C, Kirsch P, Meyer-Lindenberg A, Tost H (2014) Test-retest reliability of fMRI-based graph theoretical properties during working memory, emotion processing, and resting state. NeuroImage 84:888-900.
  •   Francois J, Grimm O, Schwarz AJ, Schweiger J, Haller L, Risterucci C, Bohringer A, Zang Z, Tost H, Gilmour G, Meyer-Lindenberg A (2016) Ketamine Suppresses the Ventral Striatal Response to Reward Anticipation: A Cross-Species Translational Neuroimaging Study. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology 41:1386-1394.
  •   Gass N, Schwarz AJ, Sartorius A, Schenker E, Risterucci C, Spedding M, Zheng L, Meyer-Lindenberg A, Weber-Fahr W (2014) Sub-Anesthetic Ketamine Modulates Intrinsic BOLD Connectivity Within the Hippocampal-Prefrontal Circuit in the Rat. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology 39:895-906.
  •   Grimm O, Gass N, Weber-Fahr W, Sartorius A, Schenker E, Spedding M, Risterucci C, Schweiger JI, Bohringer A, Zang Z, Tost H, Schwarz AJ, Meyer-Lindenberg A (2015) Acute ketamine challenge increases resting state prefrontal-hippocampal connectivity in both humans and rats. Psychopharmacology 232:4231-4241.
  •   Plichta MM, Grimm O, Morgen K, Mier D, Sauer C, Haddad L, Tost H, Esslinger C, Kirsch P, Schwarz AJ, Meyer-Lindenberg A (2014) Amygdala habituation: A reliable fMRI phenotype. NeuroImage 103:383-390.
  •   Plichta MM, Schwarz AJ, Grimm O, Morgen K, Mier D, Haddad L, Gerdes AB, Sauer C, Tost H, Esslinger C, Colman P, Wilson F, Kirsch P, Meyer-Lindenberg A (2012) Test-retest reliability of evoked BOLD signals from a cognitive-emotive fMRI test battery. NeuroImage 60:1746-1758.
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* This entry means the parameter is not applicable or has not been set.