DepressionPhase 3PUFANCT00658476
Omega-3 Fatty Acids for Treatment of Depression in Adolescents
A Phase 3 study testing Fish Oil and Cognitive Behavior Therapy in people with Depression, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Adolescence is the highest risk period for depression onset. More than 1.3 million youths suffer from major depression annually in the United States, and there is evidence for an increasing trend. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Depression
- What is being tested?
- Fish Oil and Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents between the ages of 13 and 21 currently under standard of care treatment at the Child Division of the Department of Psychiatry at CSMC
- Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria
Who cannot join
- Active suicidal ideation, with a current plan and/ or a recent suicide attempt
- Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
- History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
- Potential subjects using psychotropic medication(s), alcohol, and/ or drugs within 2 weeks prior to entry into the study (8 weeks for fluoxetine and MAOIs - monoamine oxidase inhibitors)
- Pregnant or lactating females, or those who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) and become pregnant
- Seizure or other neurological disorders
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- Dermatological conditions
- Unstable cardiac, pulmonary, endocrine, or renal disorder
- Adolescents who are currently being effectively treated with antidepressants
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Treating Adolescent Depression With Fish Oils
Adolescence is the highest risk period for depression onset. More than 1.3 million youths suffer from major depression annually in the United States, and there is evidence for an increasing trend. Because many adolescents have their first depressive episode in adolescence and adolescent depression often leads to recurrent mood disorders in adults, effective treatment during early illness can minimize the negative consequences of initial and repeated episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be useful for the treatment of depression. The purpose of this study is to investigate the safety and efficacy of PUFA for the treatment of adolescent depression.
- Conditions
- Depression
- Being tested
- Fish Oil, Cognitive Behavior Therapy, Placebo
- Keywords
- Adolescent Depression, Depression, Teenage Depression, Los Angeles
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Omega-3 fatty acid supplements.
Cognitive Behavior TherapyBehavioural
Adolescents receive cognitive behavior therapy.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements. Receives: Dietary Supplement: Fish Oil; Behavioral: Cognitive Behavior Therapy |
| Placebo | Placebo comparator | Adolescents receive cognitive behavior therapy in combination with placebo. Receives: Behavioral: Cognitive Behavior Therapy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Depression Inventory - CDI
Measured: 8 times for an average of 8 weeks
Hamilton Depression Rating Scale
Measured: 8 times for an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startNov 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Investigators
- Sayed Naqvi, M.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658476
- Sponsor's protocol ID
- 9407
- Acronym
- PUFA
- Status last verified
- Mar 2012
- First submitted
- 8 Apr 2008
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Adolescent Depression With Fish Oils
- ClinicalTrials.gov ID
- NCT00658476
- Acronym / sponsor ID
- PUFA / 9407
- Conditions
- Depression
- Keywords
- Adolescent Depression, Depression, Teenage Depression, Los Angeles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Nov 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescence is the highest risk period for depression onset. More than 1.3 million youths suffer from major depression annually in the United States, and there is evidence for an increasing trend. Because many adolescents have their first depressive episode in adolescence and adolescent depression often leads to recurrent mood disorders in adults, effective treatment during early illness can minimize the negative consequences of initial and repeated episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be useful for the treatment of depression. The purpose of this study is to investigate the safety and efficacy of PUFA for the treatment of adolescent depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | Dietary Supplement: Fish Oil, Behavioral: Cognitive Behavior TherapyAdolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements. |
| Placebo | Placebo comparator | Behavioral: Cognitive Behavior Therapy, Other: PlaceboAdolescents receive cognitive behavior therapy in combination with placebo. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents between the ages of 13 and 21 currently under standard of care treatment at the Child Division of the Department of Psychiatry at CSMC
- Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria
Key exclusion criteria (9 listed)
- Active suicidal ideation, with a current plan and/ or a recent suicide attempt
- Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
- History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
- Potential subjects using psychotropic medication(s), alcohol, and/ or drugs within 2 weeks prior to entry into the study (8 weeks for fluoxetine and MAOIs - monoamine oxidase inhibitors)
- Pregnant or lactating females, or those who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) and become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilOmega-3 fatty acid supplements. | Dietary supplement | Omega-3 Fatty Acids |
| Cognitive Behavior TherapyAdolescents receive cognitive behavior therapy. | Behavioural | Omega-3 Fatty Acids, Placebo |
| Placebo | Other | Placebo |
Primary outcome
Child Depression Inventory - CDI
Time frame: 8 times for an average of 8 weeks
Hamilton Depression Rating Scale
Time frame: 8 times for an average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayed Naqvi, M.D. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fish Oil and Cognitive Behavior Therapy in people with Depression, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Depression Inventory - CDI (time frame: 8 times for an average of 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.