Trial document




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  DRKS00000615

Trial Description

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Title

GABAergic Neurotransmission in Panic Disorder:
Psychophysical and neurochemical Predictors of Therapy Outcome

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Both, clinical effects as well as frequent abuse of substances inhibiting signal transduction in the brain (GABAergic compounds) support the deficit hypothesis of the neurotransmitter GABA in panic disorder. Further support comes from GABA receptor occupancy (as measured using PET molecular imaging) and concentration measurements of GABA using Magnetic Resonance Spectroscopy (MRS). The present study aims at evaluating a computer-based test indirectly referring to GABAergic signal transmission in Patients with panic disorder, before and after an inpatient cognitive behaviour therapy (CBT). Additionally, concentration of GABA is measured using MRS and related to findings from the above mentioned test.

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Brief Summary in Scientific Language

Magnetic Resonance Spectroscopy (MRS) of the inhibitory neurotransmitter GABA in the occipital lobe of patients with panic disorder is used together with a clinically applicable psychophysic task in order to probe the integrity of GABAergic neurotransmission. Both measurements are applied twice, before and after a structured impatient CBT, in order to evaluate their predictive value for therapy outcome and the correlation with symptom severity and symptom change.

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Organizational Data

  •   DRKS00000615
  •   2011/01/13
  •   [---]*
  •   yes
  •   Approved
  •   10-207, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F40.01 -  [generalization F40.0: Agoraphobia]
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Interventions/Observational Groups

  •   Cognitive Behavior Therapy (CBT); 6 Weeks/12 sessions
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Clinical: Change of panic symptoms according to Panic and Agroraphobia Scale (PAS: total score) after 6 weeks/12 sessions of Behavior Therapy
MR-Spectroscopy: Change of cortical GABA concentration (IU) after 6 weeks/12 sessions of Behavior Therapy
Psychophysics: Change of visual surround suppression effect ('point of subjective equivalence' in %) after 6 weeks/12 sessions of Behavior Therapy

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Secondary Outcome

Clinical: Symptom change according to Hamilton Anxiety Scale (HAM-A; total score) and Hamilton Depression Scale (HAM-D; total score) after 6 weeks/12 sessions of Behavior Therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/02/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Age: 18-60 years
Right handedness
Panic disorder (with or without agoraphobia) according to DSM-IV as primary diagnosis
PAS: 19 or greater

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Exclusion Criteria

General exclusion criteria for MRI (www.mrsafety.com)
Substance dependence or abuse
Psychotic disorders
Neurological disorders or history of brain trauma
Severe chronic somatic disorders
24h before measurement: Alcohol, Nicotine, Sleep deprivation, Drugs and psychoactive substances, particularly tranquilizer, sleep medication (except of SSRI in a stable dose since 6 weeks)
Control subjects: History of psychiatric disorders according to SCID screening

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie, UK SH, Campus Lübeck
    • Mr.  Dr. med.  Bartosz  Zurowski 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, UK SH, Campus Lübeck
    • Mr.  Dr.med.  Bartosz  Zurowski 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, UK SH, Campus Lübeck
    • Mr.  Dr.med.  Bartosz  Zurowski 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, UK SH, Campus Lübeck
    • Mr.  Dr. med.  Bartosz  Zurowski 
    • Ratzeburger Allee 160
    • 23568  Lübeck
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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