Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003309

Trial Description

start of 1:1-Block title

Title

Bright Light Treatment of non-seasonal depression for 28 adolescents

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

BLT & Depression

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Aim is the evaluation of the effect of bright light therapy in adolescents. There are already comparable data availbale for adults. We compare bright light therapy (2500 lux) with placebo (50 lux, applied 2 hours in the morning for 1 week. We check depression score and saliva melatonin (morning, evening). Hypothesis: Bright light therapy improves symptoms more than placebo. 28 adolescents with slight and moderate depressive symptoms participate. BDI and melatonin are checked 1 week before the study, just before the study, after Bright light, after placebo and 1 week later.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

We compare Bright light therapy (2500 lux) with dim light (50 lux) and evaluate improvement with BDI and melatonin.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003309
  •   2011/10/24
  •   [---]*
  •   yes
  •   Approved
  •   keine Nummer vorhanden, Ethikkommission des SKHR, beauftragt durch die Ethikkommission bei der Sächsischen Landesärztekammer
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Bright light therapy applied 2 hours in the morning for 1 week, after 1 week observation time, then 1 week placebo applied 2 hours in the morning and then 1 week observation time.
  •   placebo 50 lux applied 2 hours in the morning for one week, after 1 week observation time, then 1 week bright light therapy 2500 lux applied 2 hours in the morning, then 1 week observation time.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Depression is checked just before bright light therapy, and 1 week after bright light therapy by means of BDI and melatonin.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

to be able to see long-term effects, BDI and melatonin are checked again 1 week later.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/05/01
  •   28
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   18   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

light and moderate depression

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

manic episode, psychosis

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • SKHRO
    • Mr.  Dr.  Helmut  Niederhofer 
    • Bashnhofstraße 1
    • 08228  Rodewisch
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • SKHRO
    • Mr.  Dr.  Helmut  Niederhofer 
    • Bahnhofstraße 1
    • 08228  Rodewisch
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • SKHRO
    • Mr.  Dr.  Helmut  Niederhofer 
    • Bahnhofstraße 1
    • 08228  Rodewisch
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Sächs. KH Rodewisch
    • Mr.  Dr.  Helmut  Niederhofer 
    • Bahnhofstraße
    • 08228  Rodewisch
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2011/05/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.