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Study Title and Description

Panic disorder and social anxiety disorder subtypes in a caffeine challenge test.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on behavior*?
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Primary Publication Information
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TitleData
Title Panic disorder and social anxiety disorder subtypes in a caffeine challenge test.
Author AE Nardi,FL Lopes,RC Freire,AB Veras,I Nascimento,AM Valença,VL de-Melo-Neto,GL Soares-Filho,AL King,DM Araújo,MA Mezzasalma,A Rassi,WA Zin,
Country
Year 2009
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Behavior - Design Details - INCLUDED Studies
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 19698996
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What outcome is being evaluated in this paper? Behavior
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What is the objective of the study (as reported by the authors)? Our aim was to observe if panic disorder (PD) patients and generalized social anxiety disorder (GSAD) and performance social anxiety disorder (PSAD) patients respond in a similar way to the induction of anxiety symptoms and panic attacks by an oral caffeine challenge test. We compared 28 PD patients, 25 GSAD patients, 19 PSAD, and 26 control subjects after a 480-mg caffeine test.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) In a randomized double-blind experiment performed on two occasions 7 days apart, an oral dose of 480 mg of caffeine or a caffeine-free solution was administered in the form of instant coffee, produced regularly by a commercial coffee company. All procedures were conducted during the morning between 8 and 11 am. The decaffeinated coffee contained some small amount of caffeine as more than 97% of the caffeine was removed resulting in less than 5 mg of caffeine intake. The source of caffeine used does not guarantee that the doses given in the challenges were accurate. Most of the caffeine products (e.g. caffeine citrate) are quite bitter. In order to deal with the caffeine-free drink (placebo), we used two tablets of a low calorie sweetener sucralose (0.2 cal/tablet) in the caffeine and in the caffeine free drinks. The patient was requested to drink the coffee solution within a period of 15 min, after which a 30-min period followed before the measurements procedures, so that the caffeine could reach its peak levels in the blood (Blanchard and Sawers, 1983). To measure the baseline anxiety level, subjects were asked before each challenge test to complete the Subjective Units of Disturbance Scale (SUDS). A semiquantitative evaluation method ranging from 0 s–no anxiety to 10 s maximum anxiety level (Bech et al., 1986), and the Diagnostic Symptom Questionnaire (Sanderson et al., 1989) was adapted for DSM-IV in which the presence and level of discomfort of panic symptoms experienced after the solutions were rated on a 0- to 4- point scale ranging from 0s=none to 4 s=very severe. On the basis of the Diagnostic Symptom Questionnaire, an induced panic attack was defined as the following: 1. the presence of four or more DSM-IV panic attack symptoms where either the presence or the increase in DSM-IV symptomatology was used for diagnosis; 2. at least one DSM-IV cognitive panic symptom, i.e., fear of dying, losing control, or going crazy; 3. patient's description of the sensation of panic or fear, resembling real-life panic attacks; and 4. an agreement of two medical doctors that the patient had a clinical panic attack. The SUDS scores were not used to diagnose a panic attack. All these criteria made the diagnosis of a panic attack reliable and clinically significant.
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How many outcome-specific endpoints are evaluated? 2
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Panic attack
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes
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Clinical Clinical
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Physiological
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Other
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What is the study design? Controlled Trial
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Randomized or Non-Randomized? RCT
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What were the diagnostics or methods used to measure the outcome? Subjective
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Optional: Name of Method or short description Diagnostic Symptom Questionnaire and Subjective Units of Disturbance Scale
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Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea
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Measured Measured
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Self-report
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Children
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Adolescents
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Adults Adults
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Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Decaffeinated coffee vs caffeinated coffee
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) None specified
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Provide a general description of results (as reported by the authors). A panic attack was induced in 17 (60.7%) PD patients, in 10 (52.6%) PSAD patients, and in 4 (16.0%) GSAD patients after the caffeine test (χ2= 25.4, df= 2, Pb0.001). None of the control subjects had a panic attack after the 480-mg caffeine intake (χ2= 75.4, df= 3, Pb0.001). Neither patients nor control subjects had a panic attack after drinking the caffeine-free solution. The self-rating of SUDS before the caffeine test was 2.4±1.8 for PD; 2.1± 1.5 for GSAD; 2.2± 1.2 for PSAD, and 2.4±2.0 for the control group. After the test the ratings were 8.3± 5.6 for PD; 7.9± 5.0 for PSAD; 3.6±3.5 for GSAD; and 3.8± 3.2 for the control group.
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? NA - study authors report on the results of unhealthy population vs healthy controls
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What were the sources of funding? The research reported was supported by the Brazilian Council for Scientific and Technological Development (CNPq), Grant 554411/2005-9.
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What conflicts of interest were reported? None reported
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  Panic attack NOAEL = 480 mg/d Anxiety LOAEL = 480 mg/d
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. Anxiety levels were interpreted from the SUDS self-rating, authors did not report if increase in anxiety levels were statistically significant. Before the caffeine exposure SUDS self-rating was 2.4±2.0, after the 480 mg dose the self-rating increased to 3.8±3.2.
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What is the importance of the study with respect to the adverseness of the outcome? Important
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