Chronotherapy in children and adolescents with depression and affective dysregulation

ISRCTN ISRCTN89305231
DOI https://doi.org/10.1186/ISRCTN89305231
Secondary identifying numbers N/A
Submission date
01/08/2011
Registration date
11/08/2011
Last edited
16/01/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Chronotherapy (including light therapy) helps adults suffering from depression to get better. This initial study investigates the possible effects of chronotherapy on mood, attention and sleep in children and adolescents.

Who can participate?
You can be included when you are an inpatient between the age of 12 and 18 with a moderate to severe depression and you do not get any medication (antidepressants, neuroleptics or beta-blocker).

What does the study involve?
You will receive morning light therapy for 14 consecutive days, each day for 45 minutes at an individually determined time point that fits your biological sleep rhythm (whether you are a morning, evening or in-between type)
Two groups are compared: you either receive “active” light therapy with 10.000 Lux or “inactive” light therapy with 100 Lux
Psychological and physiological tests are made before and after the intervention and again after a few weeks to investigate changes of your depression, sleep rhythm and other parameters

What are the possible benefits and risks of participating?
Benefits of chronotherapy include symptom amelioration, additional therapeutic offer for inpatients, possibility of a treatment without medication, high predictability of the mechanisms of action.
Possible risks of chronotherapy include headache, nausea, irritability, burning eyes, unexpected awakening during the night.

Where is the study run from?
The study takes place in the LWL-University Hospital Hamm in Germany

When is the study starting and how long is it expected to run for?
The study started in August 2011 and will last until August 2014.

Who is funding the study?
Funded by the study investigator.

Who is the main contact?
Prof. Martin Holtmann
martin.holtmann@wkp-lwl.org

Contact information

Prof Martin Holtmann
Scientific

LWL University Hospital Hamm of the Ruhr- Universität Bochum
Clinic of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatic Medicine
Heithofer Allee 64
Hamm
59071
Germany

Email martin.holtmann@wkp-lwl.org

Study information

Study designDouble-blind randomized controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleChronotherapy in children and adolescents with depression and affective dysregulation: a double-blind randomized controlled trial
Study objectivesIn adults, chronotherapy has been established as an adjunctive treatment for major depression, not only for seasonal affective disorder. Preliminary results indicate that chronotherapy (light therapy, sleep deprivation, sleep phase advance) might also be helpful more generally for disorders with a disturbed circadian rhythm, such as for attention defecit hyperactivity disorder (ADHD) and affective dysregulation. Up to date, the efficacy of chronotherapy for children and adolescents has not been investigated before. The primary objective in a first pilot trial is to investigate the effects of light therapy on depression and affective dysregulation in children and adolescents.
Ethics approval(s)Ethics Committee of the Department of Medicine, Ruhr University Bochum approved on 27th June 2011 (ref: 3996-11)
Health condition(s) or problem(s) studiedJuvenile depression and affective dysregulation
InterventionPatients will be randomly assigned to the following two groups (1:1).

Experimental group
45 min morning light therapy (10.000 Lux, DAVITA LD 110) approx. 8.5 h after estimated melatonin-onset (DLMO, assessed by the morningness-eveningness-questionnaire (MEQ)) for 14 consecutive days. When there’s no improvement of depressive symptoms within the first 3 days of the intervention (assessed by the BDI II), the duration can be prolonged to 60 min to reach maximal effects.

Control group
45 min "inactive“ morning light therapy (approx. 100 Lux, DAVITA Luxor LED), approx. 8.5 h after estimated melatonin-onset (DLMO, assessed by the morningness-eveningness-questionnaire (MEQ)) for 14 consecutive days. A luxmeter (PCE-172) will ensure that the number of lux will be held constantly low.

After a "light therapy" pilot trial has been conducted, a combination trial with sleep deprivation (wake therapy), sleep phase advance and early morning light therapy will be realised.
Intervention typeOther
Primary outcome measureChange in depression rating scale at pre-test, post-test 1, post-test 2, post-test 3, post-test 4 and follow up (assessed by BDI II)
Secondary outcome measuresThe following will be assessed at pre-test, post-test 1, and follow-up:
1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at post-test 1 and follow-up)
2. Sleep parameters (Schlaffragebogen B; Görtelmeyer, 2011)
3. Number of responder [ Clinical Global Impression- Improvement (CGI-I) from 1 to 2 / 25% improvement on BDI II)
4. Strengths and Difficulties Questionnaire – parent- and self-rating (SDQ; Goodman et al., 1997)
5. Parameters of attention: alertness, flexibility, Go-No / Go, divided attention (Zimmermann & Fimm, 2009)
6. Dim Light Melantonin Onset (DLMO) and cortisol – saliva-melatonin and saliva-cortisol
7. Therapy expectancy
8. Assessment of the individual chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire, MEQ – german version; D-MEQ; Griefahn et al., 2001)
9. Child Behaviour Checklist (CBCL) / 4-18
10. Assessment of adverse events
Overall study start date01/08/2011
Completion date01/08/2014

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit12 Years
Upper age limit18 Years
SexBoth
Target number of participants30. 16/01/2014: number is 60.
Key inclusion criteria1. Moderate to severe depression [assessed by the Beck Depression Inventory (BDI) II]
2. 12-18 years of age
3. Ability of a patient to understand character and individual consequences of such a clinical trial
4. Written informed consent of the person with primary custody must be available before enrolment in the trial
Key exclusion criteria1. Acute suicidality
2. Pregnancy or lactation
3. Treatment with antidepressants
4. Treatment with beta-blocker
5. Bipolar 1 Disorder, schizophrenia
6. Diseases of the eye with involvement of the retina
7. Highly potent neuroleptics
Date of first enrolment01/08/2011
Date of final enrolment01/08/2014

Locations

Countries of recruitment

  • Germany

Study participating centre

LWL University Hospital Hamm of the Ruhr- Universität Bochum
Hamm
59071
Germany

Sponsor information

Ruhr University Bochum (Germany)
University/education

Department of Child and Adolescent
Psychiatry and Psychotherapy
Postbox 102148
Bochum
44721
Germany

Website http://www.ruhr-uni-bochum.de
ROR logo "ROR" https://ror.org/04tsk2644

Funders

Funder type

Other

Investigator initiated and funded (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 17/06/2013 Yes No