Omega-3 Fatty Acids in Adolescent Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 12 - 19 |
| Updated: | 4/21/2018 |
| Start Date: | December 2005 |
| End Date: | June 2013 |
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.
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.
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.
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
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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