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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01352 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2012-0120 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer. Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of life of patients with cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.
PRIMARY OBJECTIVE:
I. To obtain preliminary estimates of the effects of cognitive behavioral therapy (CBT) and various treatments (light therapy, melatonin, methylphenidate [methylphenidate hydrochloride]) and combinations of treatments in multimodal therapy (MMT) in reducing sleep disturbance in patients with cancer, as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores taken at baseline and on day 15.
SECONDARY OBJECTIVES:
I. To explore the effect of MMT on Insomnia Severity Index, cancer related symptoms (fatigue [Functional Assessment of Chronic Illness Therapy (FACIT-F) subscale, Edmonton Symptom Assessment System (ESAS)], anxiety, depression anxiety [Hospital Anxiety Depression Scale (HADS), ESAS]), quality of life (Functional Assessment of Cancer Therapy-General [FACT-G], ESAS), and physical activity/sleep efficacy (actigraphy), before and after treatment with various sleep disturbance (SD) treatment combinations of MMT.
II. To determine the safety of MMT (type, frequency, and severity of the adverse events).
OUTLINE: Patients are randomized to 1 of 8 treatment arms.
ARM I: Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride orally (PO) twice daily (BID) and therapeutic melatonin PO once daily (QD), and undergo light therapy over 30 minutes for 15 days.
ARM II: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
ARM III: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
ARM IV: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
ARM V: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
ARM VI: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
ARM VII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
ARM VIII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up on days 29 and 45.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (methylphenidate, melatonin, light therapy, CBT) | Experimental | Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days. |
|
| Arm II (placebo, placebo, sham light therapy, CBT) | Experimental | Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days. |
|
| Arm III (methylphenidate, melatonin, sham light therapy, CBT) | Experimental | Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days. |
|
| Arm IV (methylphenidate, placebo, light therapy, CBT) | Experimental | Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Other | Undergo CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Score Change | PSQI consists of 19 items, and it measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 (no difficulty/good) to 3 (severe difficulty/poor). The global PSQI score is then calculated by totaling (summed) seven component scores, providing an overall score ranging from 0 to 21, where 0 indicates very good sleep quality and 21 signifies very poor sleep quality. A global score of greater than 5 often suggests significant sleep problems. In this study, Wilcoxon signed-rank test was used to determine the p value. | Baseline and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change | There are 13 items in this FACIT-F subscale. In this subscale, the patient rates the intensity of fatigue and its related symptoms on a scale from 0 to 4 in the past week. The total score can range between 0 and 52, with higher scores denoting less fatigue. Wilcoxon signed-rank test was used to determine the p-value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriram Yennu | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31924662 | Derived | Yennurajalingam S, Carmack C, Balachandran D, Eng C, Lim B, Delgado M, Guzman Gutierrez D, Raznahan M, Park M, Hess KR, Williams JL, Lu Z, Ochoa J, Bruera E. Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy. BMJ Support Palliat Care. 2021 Jun;11(2):170-179. doi: 10.1136/bmjspcare-2019-001877. Epub 2020 Jan 10. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dim Red Light + Placebo + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo |
| FG001 | Bright White Light Therpay + Melatonin + Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2020 |
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| Arm V (placebo, melatonin, light therapy, CBT) | Experimental | Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days. |
|
| Arm VI (placebo, placebo, light therapy, CBT) | Experimental | Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days. |
|
| Arm VII (methylphenidate, placebo, sham light therapy, CBT) | Experimental | Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days. |
|
| Arm VIII (placebo, melatonin, sham light intervention, CBT) | Experimental | Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days. |
|
|
| Methylphenidate Hydrochloride | Drug | Given PO |
|
|
| Phototherapy | Procedure | Undergo light therapy |
|
|
| Placebo Administration | Other | Given PO |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Sham Intervention | Procedure | Undergo sham light therapy |
|
|
| Therapeutic Melatonin | Drug | Given PO |
|
|
| Baseline and Day 15 |
| Insomnia Severity Index (ISI)) Score Change | The ISI is a 7-item questionnaire designed to evaluate insomnia severity. Each item is rated using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28 with a cut-off score of 10 or greater indicating significant insomnia. Wilcoxon signed-rank test was used to determine the p-value. | Baseline and Day 15 |
| Functional Assessment of Cancer Therapy - General (FACT-G) Score Change | The FACT-G is a quality-of-life instrument that is commonly used in cancer clinical trials. FACT-G consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional and functional). The patient rates the intensity of symptoms on a Likert scale from 0 (not at all) to 4 (very much). Total score ranges from 0-108 with higher score indicates better Quality of Life. Wilcoxon signed-rank test was used to determine the p-value. | Baseline and Day 15 |
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
| FG002 | Dim Red Light + Melatonin + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days |
| FG003 | Bright White Light Therapy + Placebo + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| FG004 | Bright White Light Therapy + Placebo + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo |
| FG005 | Dim Red Light + Melatonin + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo |
| FG006 | Dim Red Light + Placebo + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| FG007 | Bright White Light Therapy + Melatonin + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dim Red Light + Placebo + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo |
| BG001 | Bright White Light Therpay + Melatonin + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo |
| BG002 | Dim Red Light + Melatonin + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days |
| BG003 | Bright White Light Therapy + Placebo + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| BG004 | Bright White Light Therapy + Placebo + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo |
| BG005 | Dim Red Light + Melatonin + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo |
| BG006 | Dim Red Light + Placebo + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| BG007 | Bright White Light Therapy + Melatonin + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Cancer Distribution of the participants | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pittsburgh Sleep Quality Index (PSQI) Score Change | PSQI consists of 19 items, and it measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 (no difficulty/good) to 3 (severe difficulty/poor). The global PSQI score is then calculated by totaling (summed) seven component scores, providing an overall score ranging from 0 to 21, where 0 indicates very good sleep quality and 21 signifies very poor sleep quality. A global score of greater than 5 often suggests significant sleep problems. In this study, Wilcoxon signed-rank test was used to determine the p value. | Those who completed the study assessment and treatment | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline and Day 15 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change | There are 13 items in this FACIT-F subscale. In this subscale, the patient rates the intensity of fatigue and its related symptoms on a scale from 0 to 4 in the past week. The total score can range between 0 and 52, with higher scores denoting less fatigue. Wilcoxon signed-rank test was used to determine the p-value. | Those who completed the study assessment and treatment | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 15 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Insomnia Severity Index (ISI)) Score Change | The ISI is a 7-item questionnaire designed to evaluate insomnia severity. Each item is rated using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28 with a cut-off score of 10 or greater indicating significant insomnia. Wilcoxon signed-rank test was used to determine the p-value. | Those who completed the study assessment and treatment | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 15 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy - General (FACT-G) Score Change | The FACT-G is a quality-of-life instrument that is commonly used in cancer clinical trials. FACT-G consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional and functional). The patient rates the intensity of symptoms on a Likert scale from 0 (not at all) to 4 (very much). Total score ranges from 0-108 with higher score indicates better Quality of Life. Wilcoxon signed-rank test was used to determine the p-value. | Those who completed the study assessment and treatment | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 15 |
|
Baseline to Day 15
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dim Red Light + Placebo + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo | 1 | 9 | 0 | 9 | 4 | 9 |
| EG001 | Bright White Light Therpay + Melatonin + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Dim Red Light + Melatonin + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days | 0 | 7 | 0 | 7 | 1 | 7 |
| EG003 | Bright White Light Therapy + Placebo + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days | 0 | 9 | 0 | 9 | 2 | 9 |
| EG004 | Bright White Light Therapy + Placebo + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo | 0 | 9 | 0 | 9 | 1 | 9 |
| EG005 | Dim Red Light + Melatonin + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo | 0 | 8 | 0 | 8 | 2 | 8 |
| EG006 | Dim Red Light + Placebo + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days | 0 | 7 | 0 | 7 | 3 | 7 |
| EG007 | Bright White Light Therapy + Melatonin + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days | 0 | 9 | 0 | 9 | 0 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Death (NOS) | General disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Oedema limbs | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hepatic Infection | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sriram Yennu, MD | M.D. Anderson Cancer Center | 713-792-6085 | syennu@mdanderson.org |
| Dec 29, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D008774 | Methylphenidate |
| D010789 | Phototherapy |
| D014467 | Ultraviolet Therapy |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| GU |
|
| Breast |
|
| GYN |
|
| Lung |
|
| Sarcoma |
|
| Other |
|
| Bright White Light Therapy + Placebo + Methylphenidate |
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| OG004 | Bright White Light Therapy + Placebo + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo |
| OG005 | Dim Red Light + Melatonin + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo |
| OG006 | Dim Red Light + Placebo + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| OG007 | Bright White Light Therapy + Melatonin + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days |
|
|
| Bright White Light Therapy + Placebo + Methylphenidate |
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| OG004 | Bright White Light Therapy + Placebo + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo |
| OG005 | Dim Red Light + Melatonin + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo |
| OG006 | Dim Red Light + Placebo + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| OG007 | Bright White Light Therapy + Melatonin + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days |
|
|
| OG003 | Bright White Light Therapy + Placebo + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| OG004 | Bright White Light Therapy + Placebo + Placebo | 1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo |
| OG005 | Dim Red Light + Melatonin + Placebo | 50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo |
| OG006 | Dim Red Light + Placebo + Methylphenidate | 50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days |
| OG007 | Bright White Light Therapy + Melatonin + Methylphenidate | 1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days |
|
|