Depressive Disorder, MajorTCT-RCTNCT03679962
Triple Chronotherapy in Adolescents
A study testing Triple Chronotherapy and Treatment as Usual in people with Depressive Disorder, Major and Bipolar Depression, run by Billings Clinic at 1 site in United States.
Trial summary
Study Purpose This study is a randomized controlled trial examining the effectiveness of TCT in the acute treatment of depression and suicidality in adolescents compared to usual treatment care, which includes individual and group therapy, and medication adjustments. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depressive Disorder, Major, Bipolar Depression, Suicidal Ideation
- What is being tested?
- Triple Chronotherapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 14 Mar 2023
- Phase
- Interventional
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient must be 12-17 years of age
- Must verbalize motivation for treatment
- Must provide informed assent; parent or guardian must provide consent
- Must be diagnosed with moderate to severe unipolar or bipolar depression. Severity of depression is determined using the Patient Health Questionnaire-9 (PHQ-9 modified for Adolescents [PHQ-A]). A score of 10 or more indicates moderate-severe depression
Who cannot join
- Active psychosis
- Manic state
- Younger than 12 years of age or older than 17 years of age
- Seizure disorder
- Pregnancy
- Lack of assent and consent
- Previous TCT treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Triple Chronotherapy in the Acute Treatment of Depression and Suicidality in the Adolescent Population: A Randomized Controlled Trial
Study Purpose This study is a randomized controlled trial examining the effectiveness of TCT in the acute treatment of depression and suicidality in adolescents compared to usual treatment care, which includes individual and group therapy, and medication adjustments. All potential participants will be identified at admission to the Psychiatric Youth Inpatient Unit of Billings Clinic and invited to participate. The length of participation is 2 months.
Study Design The primary research question of this RCT is whether adjunctive TCT in depressed adolescents is more effective in the management of depression symptoms and in reducing suicidal ideation at two months follow-up, than those adolescents who are receiving usual care. A total of three aims are proposed.
Read more
Hypothesis: Adjunctive TCT is more effective in the management of depression symptoms and in reducing suicidal ideation at two month follow-up than those adolescents who are receiving usual care.
The first aim is to track the trajectories of depression symptoms, suicidal ideation, and insomnia severity in participants receiving TCT and in those receiving treatment as usual over 4 days of initial treatment, thereby answering the question of whether adjunctive TCT can effectively reduce the severity of depression, insomnia and suicidal ideation.
The second aim is to examine whether TCT is more effective than usual care in sustaining treatment effects to the end of study period (2 months follow-up), therefore answering the question whether the effectiveness of the 4-day intervention of adjunctive TCT arm is sustainable up to the end of a two-month follow-up.
Hypothesis: TCT is more effective than usual care in sustaining treatment effects to the end of the study period than usual care.
The third aim is to assess the link to the clinical outcomes (change in depression symptoms, suicidal ideation, insomnia severity, and disease-associated quality of life) and patient satisfaction with the treatment.
Hypothesis: Clinical outcomes (depression symptoms, suicidal ideation, insomnia, and disease-related quality of life) and patient satisfaction are more effective than usual care alone.
Read the detailed description
According to the Centers for Disease Control, almost 11% of youth will have met criteria for a depressive disorder by the time they are 18 years of age. Depression can significantly impact quality of life and is associated with increased risk of suicide, the second leading cause of death among individuals between ages 10 -24 years. While evidence-based treatments for the management of depression in adolescents exist, social stigma, perception that depression can be self-managed without treatment and side effects of antidepressants all pose treatment barriers. Moreover, the two most widely used evidence-based treatments, antidepressants and cognitive behavioral therapy, have medium to small effect sizes, and a significant need exists to develop more effective strategies to manage depression in adolescents. Adjunctive treatments for depression such as electroconvulsive therapy, transcranial magnetic stimulation, and ketamine have been shown to be effective in producing an antidepressant response in the adult population; however, none are yet recommended for safe use in adolescents. Moreover, ketamine and electroconvulsive therapy are associated with significant side effects, making each a less desirable treatment for depression among adolescent patients and their families.
Chronotherapy, defined as the therapeutic manipulation of sleep-wake cycles, is a promising approach for the treatment of adolescent depression. The study of chronotherapeutic interventions as an adjunctive treatment for depression began in the 1970s, when investigators noted a rapid, albeit transient, antidepressant response to sleep deprivation. Another chronotherapeutic technique, bright light therapy, has consistently shown benefit in the treatment of seasonal affective disorders. Its use in the treatment of non-seasonal unipolar and bipolar depression has also shown promising results.
Combination chronotherapeutics, such as triple chronotherapy (TCT), have also been trialed with some demonstrated efficacy. TCT is an approach that combines sleep deprivation, bright light therapy, and sleep phase advancement in the acute treatment of depression. One of the first open label TCT studies enrolled 143 consecutive patients; of the 141 adults who completed the study, a significant acute antidepressant response was found in up to 70% of patients with bipolar depression, and a sustained response in up to 55% of patients at 1-month. A more recent randomized control trial of 75 adults employed an abbreviated protocol that included one night of sleep deprivation, three nights of sleep phase advancement, and bright light therapy in each of the four mornings of the intervention. This study demonstrated similar, accelerated antidepressant responses along with a decrease in suicidality and improved sleep quality.
Although evidence is growing for the use of TCT to manage acute depression and suicidality in adults, studies in the adolescent population are lacking. It was hypothesized by Gest et al. (2014) that the use of chronotherapy in adolescents could be an effective treatment modality, and researchers were urged to explore this area. In 2016, Gest et al. compared combined sleep deprivation and bright light therapy to bright light therapy alone in adolescents and found a significant antidepressant response to bright light therapy alone, but no significant benefit was gained with the addition of one night of total sleep deprivation. Sleep phase advancement was absent in this study. No studies were found that examined the use of comprehensive TCT in adolescents compared to usual practice in the inpatient setting.
- Being tested
- Triple Chronotherapy, Treatment as Usual
- Keywords
- Bright Light Therapy, Sleep Deprivation, Adolescent, Depression, Suicidal Ideation
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Suicidal Ideation, Sleep Deprivation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple ChronotherapyBehavioural
Day 0: One night of total sleep deprivation. The first 24 hours are spent with 1:1 nursing care for provision of comfort measures to stimulate wakefulness and to encourage completion of the intervention.
Day 1-4: Sleep phase advancement Day 1: Sleep from 6 PM to 1 AM Day 2: Sleep from 8 PM to 3 AM Day 3: Sleep from 10 PM and 5 AM Day 4: Awaken at 5 AM; discharge following light therapy
On days 1-4 patients will receive bright light therapy at 7am to 7:30am using a 10,000 Verilux light box. At discharge patients will be given a light box, strongly advised to continue the maintenance sleep schedule and bright light therapy at 7am daily for 30 minutes. Patients will be scheduled for follow-up appointments at 1-week, 1-month and 2-month following discharge.
Treatment as UsualBehavioural
Normal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions
| Study group | Role | What they receive |
|---|---|---|
| Triple Chronotherapy | Experimental | Four-day intervention, with 24-hour total sleep deprivation, 3-days of sleep phase advancement and daily bright light therapy. Receives: Behavioral: Triple Chronotherapy |
| Treatment as Usual | Active comparator | Normal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire -Adolescent version (PHQ-A)
Measuring the change score of pre-post PHQ-A; a score of 5-9 indicates mild depression with watchful waiting and repeat test, 10-14 indicates moderate depression that should be followed up with due consideration as to counseling and/or pharmacotherapy, 15-19 signifies moderately severe depression what requires initiation of pharmacotherapy and/or psychotherapy, and a score of 20-27 is interpreted as severe depression with immediate initiation of pharmacotherapy and referral to a mental health specialist for psychotherapy and collaborative management.
Measured: PHQ-A the day prior to total sleep deprivation, and then again over the next 3 consecutive days.
Columbia Suicide Severity Rating Scale
Measuring the change score of pre-post C-SSRS; 5 potential questions- yes/no questions indicating suicidal behavior and ideation; optimum score = 0.
Measured: Daily throughout the treatment (Days 0-4)
Secondary outcomes (2)
Patient Health Questionnaire-Adolescent version (PHQ-A)
Measuring the change score of pre-post PHQ-A; a score of 5-9 indicates mild depression with watchful waiting and repeat test, 10-14 indicates moderate depression that should be followed up with due consideration as to counseling and/or pharmacotherapy, 15-19 signifies moderately severe depression what requires initiation of pharmacotherapy and/or psychotherapy, and a score of 20-27 is interpreted as severe depression with immediate initiation of pharmacotherapy and referral to a mental health specialist for psychotherapy and collaborative management
Measured: PHQ-A the day prior to total sleep deprivation, and then again over the next 3 consecutive days, at 1-month and at 2-month
Youth Quality of life Questionnaire
Youth Quality of Life Instrument-Short Form (YQOL-SF); 16-questions each having a 0-10 score, higher scores indicate better quality of life.
Measured: Day 0 and repeat measure at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start25 Jan 2019
- Primary completion13 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Billings Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariela Herrera, Billings Clinic
- Investigators
- Mariela Herrera, MD, Principal investigator, Billings ClinicLaurie Riemann, BSN, Study director, Billings ClinicJamie Besel, MSN, Study chair, Billings Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679962
- Sponsor's protocol ID
- 18.26
- Acronym
- TCT-RCT
- Status last verified
- Jul 2022
- First submitted
- 24 Aug 2018
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heron M. Deaths: Leading Causes for 2014. Natl Vital Stat Rep. 2016 Jun;65(5):1-96.
PubMed 27376998Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psychiatry. 2010 Dec 30;10:113. doi: 10.1186/1471-244X-10-113.
PubMed 21192795Abdallah CG, Adams TG, Kelmendi B, Esterlis I, Sanacora G, Krystal JH. KETAMINE'S MECHANISM OF ACTION: A PATH TO RAPID-ACTING ANTIDEPRESSANTS. Depress Anxiety. 2016 Aug;33(8):689-97. doi: 10.1002/da.22501. Epub 2016 Apr 6.
PubMed 27062302Cao B, Luo Q, Fu Y, Du L, Qiu T, Yang X, Chen X, Chen Q, Soares JC, Cho RY, Zhang XY, Qiu H. Predicting individual responses to the electroconvulsive therapy with hippocampal subfield volumes in major depression disorder. Sci Rep. 2018 Apr 3;8(1):5434. doi: 10.1038/s41598-018-23685-9.
PubMed 29615675Kayser S, Bewernick BH, Wagner S, Schlaepfer TE. Clinical Predictors of Response to Magnetic Seizure Therapy in Depression: A Preliminary Report. J ECT. 2019 Mar;35(1):48-52. doi: 10.1097/YCT.0000000000000495.
PubMed 29613946Pflug B, Tolle R. Disturbance of the 24-hour rhythm in endogenous depression and the treatment of endogenous depression by sleep deprivation. Int Pharmacopsychiatry. 1971;6(3):187-96. doi: 10.1159/000468269. No abstract available.
PubMed 4950570Nussbaumer B, Kaminski-Hartenthaler A, Forneris CA, Morgan LC, Sonis JH, Gaynes BN, Greenblatt A, Wipplinger J, Lux LJ, Winkler D, Van Noord MG, Hofmann J, Gartlehner G. Light therapy for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2015 Nov 8;(11):CD011269. doi: 10.1002/14651858.CD011269.pub2.
PubMed 26558494Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;2004(2):CD004050. doi: 10.1002/14651858.CD004050.pub2.
PubMed 15106233Al-Karawi D, Jubair L. Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. J Affect Disord. 2016 Jul 1;198:64-71. doi: 10.1016/j.jad.2016.03.016. Epub 2016 Mar 15.
PubMed 27011361Benedetti F, Riccaboni R, Locatelli C, Poletti S, Dallaspezia S, Colombo C. Rapid treatment response of suicidal symptoms to lithium, sleep deprivation, and light therapy (chronotherapeutics) in drug-resistant bipolar depression. J Clin Psychiatry. 2014 Feb;75(2):133-40. doi: 10.4088/JCP.13m08455.
PubMed 24345382Martiny K, Refsgaard E, Lund V, Lunde M, Sorensen L, Thougaard B, Lindberg L, Bech P. A 9-week randomized trial comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine. J Clin Psychiatry. 2012 Sep;73(9):1234-42. doi: 10.4088/JCP.11m07625.
PubMed 23059149Martiny K, Refsgaard E, Lund V, Lunde M, Thougaard B, Lindberg L, Bech P. Maintained superiority of chronotherapeutics vs. exercise in a 20-week randomized follow-up trial in major depression. Acta Psychiatr Scand. 2015 Jun;131(6):446-57. doi: 10.1111/acps.12402. Epub 2015 Feb 17.
PubMed 25689725Gest S, Legenbauer T, Bogen S, Schulz C, Pniewski B, Holtmann M. Chronotherapeutics: an alternative treatment of juvenile depression. Med Hypotheses. 2014 Mar;82(3):346-9. doi: 10.1016/j.mehy.2014.01.002. Epub 2014 Jan 15.
PubMed 24468576Gest S, Holtmann M, Bogen S, Schulz C, Pniewski B, Legenbauer T. Chronotherapeutic treatments for depression in youth. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):151-61. doi: 10.1007/s00787-015-0720-6. Epub 2015 May 17.
PubMed 25982568
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Triple Chronotherapy in the Acute Treatment of Depression and Suicidality in the Adolescent Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03679962
- Acronym / sponsor ID
- TCT-RCT / 18.26
- Keywords
- Bright Light Therapy, Sleep Deprivation, Adolescent, Depression, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Billings ClinicUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 21 Sep 2018 (actual)
- 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.
Study Purpose This study is a randomized controlled trial examining the effectiveness of TCT in the acute treatment of depression and suicidality in adolescents compared to usual treatment care, which includes individual and group therapy, and medication adjustments. All potential participants will be identified at admission to the Psychiatric Youth Inpatient Unit of Billings Clinic and invited to participate. The length of participation is 2 months.
Study Design The primary research question of this RCT is whether adjunctive TCT in depressed adolescents is more effective in the management of depression symptoms and in reducing suicidal ideation at two months follow-up, than those adolescents who are receiving usual care. A total of three aims are proposed.
Hypothesis: Adjunctive TCT is more effective in the management of depression symptoms and in reducing suicidal ideation at two month follow-up than those adolescents who are receiving usual care.
The first aim is to track the trajectories of depression symptoms, suicidal ideation, and insomnia severity in participants receiving TCT and in those receiving treatment as usual over 4 days of initial treatment, thereby answering the question of whether adjunctive TCT can effectively reduce the severity of depression, insomnia and suicidal ideation.
The second aim is to examine whether TCT is more effective than usual care in sustaining treatment effects to the end of study period (2 months follow-up), therefore answering the question whether the effectiveness of the 4-day intervention of adjunctive TCT arm is sustainable up to the end of a two-month follow-up.
Hypothesis: TCT is more effective than usual care in sustaining treatment effects to the end of the study period than usual care.
The third aim is to assess the link to the clinical outcomes (change in depression symptoms, suicidal ideation, insomnia severity, and disease-associated quality of life) and patient satisfaction with the treatment.
Hypothesis: Clinical outcomes (depression symptoms, suicidal ideation, insomnia, and disease-related quality of life) and patient satisfaction are more effective than usual care alone.
Detailed description
According to the Centers for Disease Control, almost 11% of youth will have met criteria for a depressive disorder by the time they are 18 years of age. Depression can significantly impact quality of life and is associated with increased risk of suicide, the second leading cause of death among individuals between ages 10 -24 years. While evidence-based treatments for the management of depression in adolescents exist, social stigma, perception that depression can be self-managed without treatment and side effects of antidepressants all pose treatment barriers. Moreover, the two most widely used evidence-based treatments, antidepressants and cognitive behavioral therapy, have medium to small effect sizes, and a significant need exists to develop more effective strategies to manage depression in adolescents. Adjunctive treatments for depression such as electroconvulsive therapy, transcranial magnetic stimulation, and ketamine have been shown to be effective in producing an antidepressant response in the adult population; however, none are yet recommended for safe use in adolescents. Moreover, ketamine and electroconvulsive therapy are associated with significant side effects, making each a less desirable treatment for depression among adolescent patients and their families.
Chronotherapy, defined as the therapeutic manipulation of sleep-wake cycles, is a promising approach for the treatment of adolescent depression. The study of chronotherapeutic interventions as an adjunctive treatment for depression began in the 1970s, when investigators noted a rapid, albeit transient, antidepressant response to sleep deprivation. Another chronotherapeutic technique, bright light therapy, has consistently shown benefit in the treatment of seasonal affective disorders. Its use in the treatment of non-seasonal unipolar and bipolar depression has also shown promising results.
Combination chronotherapeutics, such as triple chronotherapy (TCT), have also been trialed with some demonstrated efficacy. TCT is an approach that combines sleep deprivation, bright light therapy, and sleep phase advancement in the acute treatment of depression. One of the first open label TCT studies enrolled 143 consecutive patients; of the 141 adults who completed the study, a significant acute antidepressant response was found in up to 70% of patients with bipolar depression, and a sustained response in up to 55% of patients at 1-month. A more recent randomized control trial of 75 adults employed an abbreviated protocol that included one night of sleep deprivation, three nights of sleep phase advancement, and bright light therapy in each of the four mornings of the intervention. This study demonstrated similar, accelerated antidepressant responses along with a decrease in suicidality and improved sleep quality.
Although evidence is growing for the use of TCT to manage acute depression and suicidality in adults, studies in the adolescent population are lacking. It was hypothesized by Gest et al. (2014) that the use of chronotherapy in adolescents could be an effective treatment modality, and researchers were urged to explore this area. In 2016, Gest et al. compared combined sleep deprivation and bright light therapy to bright light therapy alone in adolescents and found a significant antidepressant response to bright light therapy alone, but no significant benefit was gained with the addition of one night of total sleep deprivation. Sleep phase advancement was absent in this study. No studies were found that examined the use of comprehensive TCT in adolescents compared to usual practice in the inpatient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Triple Chronotherapy | Experimental | Behavioral: Triple ChronotherapyFour-day intervention, with 24-hour total sleep deprivation, 3-days of sleep phase advancement and daily bright light therapy. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualNormal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient must be 12-17 years of age
- Must verbalize motivation for treatment
- Must provide informed assent; parent or guardian must provide consent
- Must be diagnosed with moderate to severe unipolar or bipolar depression. Severity of depression is determined using the Patient Health Questionnaire-9 (PHQ-9 modified for Adolescents [PHQ-A]). A score of 10 or more indicates moderate-severe depression
Key exclusion criteria (7 listed)
- Active psychosis
- Manic state
- Younger than 12 years of age or older than 17 years of age
- Seizure disorder
- Pregnancy
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 |
|---|---|---|
| Triple ChronotherapyDay 0: One night of total sleep deprivation. The first 24 hours are spent with 1:1 nursing care for provision of comfort measures to stimulate wakefulness and to encourage completion of the intervention. Day 1-4: Sleep phase advancement Day 1: Sleep from 6 PM to 1 AM Day 2: Sleep from 8 PM to 3 AM Day 3: Sleep from 10 PM and 5 AM Day 4: Awaken at 5 AM; discharge following light therapy On days 1-4 patients will receive bright light therapy at 7am to 7:30am using a 10,000 Verilux light box. At discharge patients will be given a light box, strongly advised to continue the maintenance sleep schedule and bright light therapy at 7am daily for 30 minutes. Patients will be scheduled for follow-up appointments at 1-week, 1-month and 2-month following discharge. | Behavioural | Triple Chronotherapy |
| Treatment as UsualNormal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions | Behavioural | Treatment as Usual |
Primary outcome
Patient Health Questionnaire -Adolescent version (PHQ-A)
Time frame: PHQ-A the day prior to total sleep deprivation, and then again over the next 3 consecutive days.
Measuring the change score of pre-post PHQ-A; a score of 5-9 indicates mild depression with watchful waiting and repeat test, 10-14 indicates moderate depression that should be followed up with due consideration as to counseling and/or pharmacotherapy, 15-19 signifies moderately severe depression what requires initiation of pharmacotherapy and/or psychotherapy, and a score of 20-27 is interpreted as severe depression with immediate initiation of pharmacotherapy and referral to a mental health specialist for psychotherapy and collaborative management.
Columbia Suicide Severity Rating Scale
Time frame: Daily throughout the treatment (Days 0-4)
Measuring the change score of pre-post C-SSRS; 5 potential questions- yes/no questions indicating suicidal behavior and ideation; optimum score = 0.
2 secondary outcomes
Patient Health Questionnaire-Adolescent version (PHQ-A)
Time frame: PHQ-A the day prior to total sleep deprivation, and then again over the next 3 consecutive days, at 1-month and at 2-month
Youth Quality of life Questionnaire
Time frame: Day 0 and repeat measure at 30 days
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 16 Aug 2023.
- Background: PubMed 27376998Heron M. Deaths: Leading Causes for 2014. Natl Vital Stat Rep. 2016 Jun;65(5):1-96.
- Background: PubMed 21192795Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psychiatry. 2010 Dec 30;10:113. doi: 10.1186/1471-244X-10-113.
- Background: PubMed 27062302Abdallah CG, Adams TG, Kelmendi B, Esterlis I, Sanacora G, Krystal JH. KETAMINE'S MECHANISM OF ACTION: A PATH TO RAPID-ACTING ANTIDEPRESSANTS. Depress Anxiety. 2016 Aug;33(8):689-97. doi: 10.1002/da.22501. Epub 2016 Apr 6.
- Background: PubMed 29615675Cao B, Luo Q, Fu Y, Du L, Qiu T, Yang X, Chen X, Chen Q, Soares JC, Cho RY, Zhang XY, Qiu H. Predicting individual responses to the electroconvulsive therapy with hippocampal subfield volumes in major depression disorder. Sci Rep. 2018 Apr 3;8(1):5434. doi: 10.1038/s41598-018-23685-9.
- Background: PubMed 29613946Kayser S, Bewernick BH, Wagner S, Schlaepfer TE. Clinical Predictors of Response to Magnetic Seizure Therapy in Depression: A Preliminary Report. J ECT. 2019 Mar;35(1):48-52. doi: 10.1097/YCT.0000000000000495.
- Background: PubMed 4950570Pflug B, Tolle R. Disturbance of the 24-hour rhythm in endogenous depression and the treatment of endogenous depression by sleep deprivation. Int Pharmacopsychiatry. 1971;6(3):187-96. doi: 10.1159/000468269. No abstract available.
- Background: PubMed 26558494Nussbaumer B, Kaminski-Hartenthaler A, Forneris CA, Morgan LC, Sonis JH, Gaynes BN, Greenblatt A, Wipplinger J, Lux LJ, Winkler D, Van Noord MG, Hofmann J, Gartlehner G. Light therapy for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2015 Nov 8;(11):CD011269. doi: 10.1002/14651858.CD011269.pub2.
- Background: PubMed 15106233Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;2004(2):CD004050. doi: 10.1002/14651858.CD004050.pub2.
- Background: PubMed 27011361Al-Karawi D, Jubair L. Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. J Affect Disord. 2016 Jul 1;198:64-71. doi: 10.1016/j.jad.2016.03.016. Epub 2016 Mar 15.
- Background: PubMed 24345382Benedetti F, Riccaboni R, Locatelli C, Poletti S, Dallaspezia S, Colombo C. Rapid treatment response of suicidal symptoms to lithium, sleep deprivation, and light therapy (chronotherapeutics) in drug-resistant bipolar depression. J Clin Psychiatry. 2014 Feb;75(2):133-40. doi: 10.4088/JCP.13m08455.
- Background: PubMed 23059149Martiny K, Refsgaard E, Lund V, Lunde M, Sorensen L, Thougaard B, Lindberg L, Bech P. A 9-week randomized trial comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine. J Clin Psychiatry. 2012 Sep;73(9):1234-42. doi: 10.4088/JCP.11m07625.
- Background: PubMed 25689725Martiny K, Refsgaard E, Lund V, Lunde M, Thougaard B, Lindberg L, Bech P. Maintained superiority of chronotherapeutics vs. exercise in a 20-week randomized follow-up trial in major depression. Acta Psychiatr Scand. 2015 Jun;131(6):446-57. doi: 10.1111/acps.12402. Epub 2015 Feb 17.
- National Institute of Mental Health. Mental Health Information. 2015Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mariela Herrera, MD principal investigator
Billings Clinic
Laurie Riemann, BSN study director
Billings Clinic
Jamie Besel, MSN study chair
Billings Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple Chronotherapy and Treatment as Usual in people with Depressive Disorder, Major and Bipolar Depression, run by Billings Clinic at 1 site in United States.
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 4 inclusion and 7 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 16 Aug 2023. 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 United States. 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.
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?
Patient Health Questionnaire -Adolescent version (PHQ-A) (time frame: PHQ-A the day prior to total sleep deprivation, and then again over the next 3 consecutive 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?
On the ClinicalTrials.gov record for NCT03679962, which also lists 14 linked publications.
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 16 Aug 2023.