Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)

This study has been completed.
Sponsor:
Collaborator:
Daacro
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01665170
First received: August 1, 2012
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation

Condition Intervention Phase
Healthy
Stress
Drug: Passiflora incarnata
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Pilot Study on the Efficacy of Passiflora Incarnata L. in an Acute Stressful Situation

Resource links provided by NLM:


Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • VAS Insecurity (During) [ Time Frame: during stress test = Visite 3 ] [ Designated as safety issue: No ]
    The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

  • VAS Anxiety (During) [ Time Frame: during stress test = Visite 3 ] [ Designated as safety issue: No ]
    The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

  • VAS Stress Perception (During) [ Time Frame: during stress test = Visite 3 ] [ Designated as safety issue: No ]
    The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.


Secondary Outcome Measures:
  • Serum Cortisol (Pre-post Comparison) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    2 min. prior to and 1 min. after the TSST

  • ACTH (Pre-post Comparison) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST

  • Epinephrine (Before) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    2 min. prior the TSST

  • Norepinephrine (Before) [ Time Frame: before stress test ] [ Designated as safety issue: No ]
    2 min. prior the TSST

  • State Anxiety (STAI-X1) Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = "not at all" to 4 = "very true". The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3

  • POMS Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = "not at all" to 7 = "very strongly". The questionnaire is completed on V2 and V3.

  • MDBF Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = "not at all" to 5 = "very true". To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3

  • LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.

    V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome.


  • LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3 [ Time Frame: Visite 2, visite 3 ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.

    V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.


  • LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3 [ Time Frame: Visite 2 (before treatment), Visite 3 (after treatment) ] [ Designated as safety issue: No ]

    The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

    The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome.


  • Norepinephrine (After) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    2 min. after the TSST, higher value is better

  • Sympathovagal Balance (Before TSST, Sitting - 1. Measurement) [ Time Frame: before TSST ] [ Designated as safety issue: No ]
    Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

  • Sympathovagal Balance (Before TSST, Standing - 2. Measurement) [ Time Frame: before TSST ] [ Designated as safety issue: No ]
    Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

  • Sympathovagal Balance (During TSST, Preparation - 3. Measurement) [ Time Frame: during TSST ] [ Designated as safety issue: No ]
    Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

  • Sympathovagal Balance (During TSST, Interview - 4. Measurement) [ Time Frame: during TSST ] [ Designated as safety issue: No ]
    Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

  • Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement) [ Time Frame: during TSST ] [ Designated as safety issue: No ]
    Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

  • Sympathovagal Balance (After TSST, Standing - 6. Measurement) [ Time Frame: after TSST ] [ Designated as safety issue: No ]
    Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

  • Sympathovagal Balance (After TSST, Sitting - 7. Measurement) [ Time Frame: after TSST ] [ Designated as safety issue: No ]
    Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.


Enrollment: 60
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo arm
Drug: Placebo
3 x 1 ablet per day for 3 days
Active Comparator: Verum
Verum arm - Pascoflair 425mg
Drug: Passiflora incarnata
3 x 1 tablet per day for 3 days
Other Name: Pascoflair 425mg coated tablets

Detailed Description:
Randomized, double-blind, placebo-controlled, single-center study During Visit 1 study information and an informed consent form are handed out. After study inclusion on Visit 2, participants are assigned to one of two groups at random and receive the test products (either Pascoflair® or placebo tablets). The 3rd visit includes the completion of questionnaires regarding wellbeing and the Trier Social Stress Test.
  Eligibility

Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provide written informed consent;
  • Healthy male and female subjects
  • Non-smoker;
  • Age 25 to 45 years;
  • BMI ≥ 19 to ≤ 30 kg/m2

Exclusion Criteria:

  • Any known allergies to the test substance;
  • Any known addiction to drugs, alcohol or positive results in the drug screening test;
  • Any serious general illness, ongoing or within the last 12 months;
  • Any febrile illness (> 24 hrs.) within 7 days prior to treatment;
  • Any antibiotics for the last four weeks before study inclusion;
  • Diabetes mellitus;
  • Known heart disease, hypertension, kidney disease, significant respiratory disease, epilepsy, or rheumatoid arthritis;
  • Known immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS) which could place the subject at risk or interfere with the accuracy of the study results;
  • Pregnancy or lactating;
  • Current participation or participation in any type of clinical study in the past week;
  • Current or past participation in a TSST study;
  • Employees of the Sponsor or the CRO;
  • Any other medication that, in the opinion of the Investigator is likely to affect their response to treatment;
  • Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, or haematology as judged by the Investigator;
  • Any other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665170

Locations
Germany
Juliane Hellhammer
Trier, Germany, 54296
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Daacro
Investigators
Principal Investigator: Michael Clemens, MD, Prof Klinikum Mutterhaus der Borromäerinnen GmbH, Feldstr. 16, 54290 Trier
  More Information

Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01665170     History of Changes
Other Study ID Numbers: 178 S11 PF  2011-006129-17 
Study First Received: August 1, 2012
Results First Received: June 12, 2013
Last Updated: November 4, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
Pascoflair
tsst
passiflora incarnata
non smoking male
and female volunteers

ClinicalTrials.gov processed this record on August 23, 2016