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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT002395-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1) change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end of 10-week treatment.
Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo.
Title: Omega-3 Fatty Acids in Adolescents with Depression
NOTE: No individual will be advised to terminate ongoing treatment. If adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. However, psychotherapy cannot be initiated at the time of entry into the study.
Aim: To provide preliminary clinical data about the efficacy of omega-3FA (derived from fish oil) in the treatment of adolescent MDD. A NCCAM/NIH-funded study.
Summary: Informed consent will be obtained from parent/guardian and assent obtained from participant. Interested participants will have a free diagnostic evaluation by study psychiatrist to determine eligibility. Routine blood tests and a urine pregnancy test will be obtained. Eligible participants will be randomized to receive either omega-3FA or matching placebo (corn oil) for 10 weeks. Patients will be seen weekly throughout the trial. Dosage will be titrated based on clinical response and side effects. At end of double-blind phase, participants will be referred to a clinician who will be informed of subjects' treatment. Depending on treatment received during double-blind phase, post-study treatment options will include treatment with omega-3 fatty acids or an SSRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| corn oil | Placebo Comparator | as stated |
|
| Omega 3 Fatty Acids | Experimental | as stated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acids | Drug | 10 wk treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Children's Depressive Rating Scale - Revised (CDRS-R) | It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms). | baseline and 10-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician's Global Improvement Scale (CGI) | a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | baseline and 10-week treatment phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vilma Gabbay, M.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
57 were consented, 6 did not meet eligibility and were not randomized. 3 participants enrolled in Omega-3 Fatty Acids arm but discontinued prior to receiving treatment and not included in analysis.
Recruitment began in December 2005, with enrollment from January 2006 to June 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Corn Oil | The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell. |
| FG001 | Omega-3 Fatty Acids | The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. Acids: 10 wk treatment period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
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| ID | Title | Description |
|---|---|---|
| BG000 | Corn Oil | The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Children's Depressive Rating Scale - Revised (CDRS-R) | It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms). | 3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results | Posted | Mean | Standard Deviation | units on a scale | baseline and 10-weeks |
|
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3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
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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 | Corn Oil | The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin rash | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vilma Gabbay | Icahn School of Medicine at Mount Sinai | 212-659-1661 | vilma.gabbay@mssm.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| corn oil | Drug | placebo comparator |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Pregnancy |
|
| discontinued prior to getting treatment |
|
| Omega 3 Fatty Acids |
The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Omega-3 Fatty Acids | The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. |
|
|
| Secondary | Clinician's Global Improvement Scale (CGI) | a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | 3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results | Posted | Mean | Standard Deviation | units on a scale | baseline and 10-week treatment phase |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 1 |
| 27 |
| EG001 | Omega-3 Fatty Acids | The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |