NCT01187797

Brief Summary

The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 25, 2010

Status Verified

August 1, 2010

Enrollment Period

1 month

First QC Date

August 9, 2010

Last Update Submit

October 22, 2010

Conditions

Outcome Measures

Primary Outcomes (2)

  • Depression

    Depression scores will be evaluated with the BDI

    After 10 days

  • Somatization

    Somatization will be assessed with the SOMS7 questionnaire

    After 10 days

Study Arms (1)

Intervention

EXPERIMENTAL
Other: Emotional stimulation

Interventions

Increase of the physical correlates of an emotion

Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 45
  • Ability to speak German

You may not qualify if:

  • Physical or psychiatric disorders
  • Consume of drugs or alcohol 24 previous to the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 12200, Germany

Location

MeSH Terms

Conditions

DepressionSomatoform DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • fernando Dimeo, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 24, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 25, 2010

Record last verified: 2010-08

Locations