Adolescent Depression
Conditions
Keywords
Adolescents, Depression, Fish Oil, Omega-3 Fatty Acids, Psychiatry
Brief summary
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.
Detailed description
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.
Interventions
DRUGOmega-3 Fatty Acids
10 wk treatment period
DRUGcorn oil
placebo comparator
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
National Center for Research Resources (NCRR)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Age: 12-19 * Depressed with DSM-IV diagnosis of MDD * Duration of depressive episode greater than 6 weeks
Exclusion criteria
* Current or past DSM-IV-TR bipolar, schizophrenia, psychosis, pervasive developmental disorder (PDD), and Tourette's disorder. * Current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic stress, and/or substance-related disorders (other than nicotine). * Adolescents who present with current suicidal ideation with intent or plan, or who may pose a danger to themselves. * Current antidepressant treatment, or taken within 60 days prior to enrollment * Neuroleptics taken within 90 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Depressive Rating Scale - Revised (CDRS-R) | baseline and 10-weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician's Global Improvement Scale (CGI) | baseline and 10-week treatment phase | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in December 2005, with enrollment from January 2006 to June 2013
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 21 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | discontinued prior to getting treatment | 0 | 3 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Corn Oil | Omega 3 Fatty Acids | Total |
|---|---|---|---|
| Age, Continuous | 16.34 years STANDARD_DEVIATION 1.981 | 15.68 years STANDARD_DEVIATION 2.19 | 16.05 years STANDARD_DEVIATION 2.079 |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 28 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 21 |
| other Total, other adverse events | 1 / 27 | 0 / 21 |
| serious Total, serious adverse events | 0 / 27 | 0 / 21 |
Outcome results
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).
Time frame: baseline and 10-weeks
Population: 3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corn Oil | Children's Depressive Rating Scale - Revised (CDRS-R) | Baseline | 50.2 units on a scale | Standard Deviation 8.91 |
| Corn Oil | Children's Depressive Rating Scale - Revised (CDRS-R) | 10 weeks | 35.2 units on a scale | Standard Deviation 10.57 |
| Omega-3 Fatty Acids | Children's Depressive Rating Scale - Revised (CDRS-R) | Baseline | 49.5 units on a scale | Standard Deviation 8.2 |
| Omega-3 Fatty Acids | Children's Depressive Rating Scale - Revised (CDRS-R) | 10 weeks | 36.5 units on a scale | Standard Deviation 10.01 |
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.
Time frame: baseline and 10-week treatment phase
Population: 3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corn Oil | Clinician's Global Improvement Scale (CGI) | Baseline | 4.0 units on a scale | Standard Deviation 0.5 |
| Corn Oil | Clinician's Global Improvement Scale (CGI) | 10 weeks | 3.2 units on a scale | Standard Deviation 0.75 |
| Omega-3 Fatty Acids | Clinician's Global Improvement Scale (CGI) | Baseline | 4.0 units on a scale | Standard Deviation 0.34 |
| Omega-3 Fatty Acids | Clinician's Global Improvement Scale (CGI) | 10 weeks | 3.4 units on a scale | Standard Deviation 0.86 |