DepressionPhase 1/2NCT01187797
Effects of Emotional Stimulation on the Stress Levels of Healthy Persons
A Phase 1/2 study testing Emotional stimulation in people with Depression and Somatization Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Somatization Disorder, Anger
- What is being tested?
- Emotional stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45
- Ability to speak German
Who cannot join
- Physical or psychiatric disorders
- Consume of drugs or alcohol 24 previous to the test
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 12200
About this study
Official title: Evaluation of the Effects of a Body-centered Emotional Stimulation in Healthy Persons
The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.
Read the detailed description
The trial assesses the effects of a emotion-centered stimulation on the mood of healthy persons. The outcomes will be evaluated with standard questionnaires.
- Conditions
- Depression, Somatization Disorder, Anger, Anxiety
- Being tested
- Emotional stimulation
- Medical subject headings
- Depression, Somatoform Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional stimulationOther
Increase of the physical correlates of an emotion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Emotional stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depression scores will be evaluated with the BDI
Measured: After 10 days
Somatization
Somatization will be assessed with the SOMS7 questionnaire
Measured: After 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- fernando Dimeo, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187797
- Sponsor's protocol ID
- EA408109
- Status last verified
- Aug 2010
- First submitted
- 9 Aug 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of a Body-centered Emotional Stimulation in Healthy Persons
- ClinicalTrials.gov ID
- NCT01187797
- Acronym / sponsor ID
- EA408109
- Conditions
- Depression, Somatization Disorder, Anger, Anxiety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.
Detailed description
The trial assesses the effects of a emotion-centered stimulation on the mood of healthy persons. The outcomes will be evaluated with standard questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Emotional stimulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 45
- Ability to speak German
Key exclusion criteria (2 listed)
- Physical or psychiatric disorders
- Consume of drugs or alcohol 24 previous to the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional stimulationIncrease of the physical correlates of an emotion | Other | Intervention |
Primary outcome
Depression
Time frame: After 10 days
Depression scores will be evaluated with the BDI
Somatization
Time frame: After 10 days
Somatization will be assessed with the SOMS7 questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fernando Dimeo, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Emotional stimulation in people with Depression and Somatization Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: After 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2010.