Sleep, wake and light therapy for depression: a randomised parallel trial

Phase 2

Completed

• Conditions: nipolar major depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN17706836
• Lead Sponsor: South London and Maudsley NHS Foundation Trust

Brief Summary

2021 Results article in https://doi.org/10.1192/bjo.2021.1044 (added 09/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-22
• Study Completion: 2019-08-31
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

1. Diagnosis of Depressive Episode (ICD10 F32) or Recurrent Depressive Disorder (F33)
2. Minimum score of 8 or more on the Hamilton Depression Rating Scale (6 item) (Range 0-22) (Bech,1981)
3. Age 18-65
4. Able to give informed consent
5. Women of child bearing age may be included and no methods of contraception is required to enable inclusion into the trial

Exclusion Criteria

1. Current diagnosis of Seasonal Affective Disorder
2. Current diagnosis of anorexia nervosa or bulimia
3. Current diagnosis of an obsessive compulsive or related disorder
4. Current diagnosis of post-traumatic stress disorder
5. History of schizophrenia, schizoaffective disorder or bipolar disorder
6. Severe cognitive impairment, dementia, intellectual disability or organic brain disorder
7. History of stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence in past 3 months
8. Borderline Personality Disorder or other personality disorder considered to be the main problem
9. Duration of depression more than 2 years
10. Significant risk of suicide that requires hospitalisation
11. Severe eye disease or cataracts or traumatic injury or visual impairment affecting both eyes
12. History of epilepsy, uncontrolled severe headaches, or stroke as this may lower seizure threshold through sleep deprivation
13. Unstable medical condition that would make wake therapy intolerable
14. Untreated sleep disorder such as obstructive sleep apnoea or narcolepsy
15. Use of photo-sensitizing drugs
16. Current night-shift work
17. Non-English speaker

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of participants recruited per month/adherence to the protocol, measured during Week 1