E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Improvent of physical and psychological stamina. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients in the ages 20 to 55, of both sexes. Referred by a physician and subjectively estimating his/her difficulties as equivalent to the criteria for “fatigue syndrome” suggested by the National board of health and welfare in Sweden. The ICD-code for fatigue syndrome will be F43.8A from 050101. Criteria in appendix 1. These criteria are more conservative than criteria normally used for “burnout”. This will have as a result that all patients included also fulfill criteria for “burnout”. In diagnosing subjects ratings on two fatigue scales (Pine’s burnout measure and Karolinska Utbrändhetsskala) Appendix , a symptom rating and additional questions about time and causes in a questionnaire is used. Diagnosis will be made in one of three ways:
1. Available information is taken into account by a licensed physician which make the diagnosis on basis of all available information including above mentioned subjective data and written referrals. 2. A licensed psychologist meet with the subject for 45 minutes and take into account above mentioned questionnaire and referral. On this basis the psychologist make the diagnosis. 3. A licensed physician meet with the subject 30 minutes and take into account above mentioned questionnaire and referral. On this basis the physician make the diagnosis.
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E.4 | Principal exclusion criteria |
Excluded are subjects with co morbidity of other serious diagnosis. Patients with following diagnosis are excluded: heart disease, stroke, insulin-dependent diabetes, cancer, drug addiction and high consumption of alcohol, stomach ulcers, food- and medication-allergy, asthma, psychosis, depressive episode. Excluded are also high nicotine-consumption, pregnancy or lactation. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome-measures are Quality of Life measured in some aspects with the SF-36 questionnaire. Perhaps the most used QoL-instrument with good psychometric properties even for the Swedish translation (Persson, Karlsson, Bengtsson, Steen, & Sullivan, 1998; Sullivan, 1994; Sullivan & Karlsson, 1998; Sullivan, Karlsson, & Ware, 1995).
Symptom reduction is measured with Pine´s Burnout Measure. A questionnaire with good psychometric properties. The Swedish translation is well used and tested (Hallsten, Bellaagh, & Gustafsson, 2002).
The other fatigue and burnout measure which will be used is Karolinska Utbrändhetsskala (Perski, 2002). This scale is under extensive testing right now and the results will be publicized under 2005. This scale has 4 subscales.
Montgomery Asberg Depression Rating Scale (MADRS) is a subjective measure of depressive symptoms which is sensitive to change. Good psychometric properties are reported (Montgomery & Asberg, 1979).
Stress Medicine Symptom Scale covers 14 stress related somatic symptoms. This is a straight forward symptom likert scale in 7 steps which has good psychometric properties, i.e. reliability over three months (test-retest) and validated against SCL-90s subscale somatisation (Derogatis & Cleary, 1977; Olsson, unpublished data)
Cortisol response to awakening is measured with repeated saliva samples according to a principle used in study of burn-out syndrome and Chronic Fatigue Syndrome (de Vente, Olff, van Amsterdam, Kamphuis, & Emmelkamp, 2003; Pruessner, Hellhammer, & Kirschbaum, 1999; Roberts, Wessely, Chalder, Papadopoulos, & Cleare, 2004). Four saliva samples are taken at awakening and 15, 45 and 60 minutes later. The response curve is typically lower in fatigued subjects.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |