Omega-3 Fatty Acids in Adolescent Depression

Adolescent Depression Clinical Trial

Official title:

Omega-3 Fatty Acids in Adolescent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312897
• Other study ID #: GCO# 12-1321
• Secondary ID: R21AT002395-01A2
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2006
• Last updated: March 20, 2018
• Start date: December 2005
• Est. completion date: June 2013

Study information

• Verified date: March 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Omega-3 Fatty Acids
10 wk treatment period
• corn oil
placebo comparator

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Center for Complementary and Integrative Health (NCCIH), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	baseline and 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.	baseline and 10-week treatment phase