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Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania (R34)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00917501
First received: June 8, 2009
Last updated: May 2, 2016
Last verified: May 2016
Results First Received: October 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Mania
Interventions: Drug: OMega 3
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Olive oil - 3 capsules/day
Omega-3 Fish oil - 3 capsules/day

Participant Flow:   Overall Study
    Placebo     Omega-3  
STARTED     29     26  
COMPLETED     21     21  
NOT COMPLETED     8     5  
Lost to Follow-up                 4                 1  
Withdrawal by Subject                 3                 1  
Lack of Efficacy                 1                 2  
trouble swollowing capsules                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Olive oil - 3 capsules/day
Omega-3 Fish oil - 3 capsules/day
Total Total of all reporting groups

Baseline Measures
    Placebo     Omega-3     Total  
Number of Participants  
[units: participants]
  29     26     55  
Age  
[units: Years]
Mean (Standard Deviation)
  13.4  (3.3)     13  (4.5)     13.2  (3.9)  
Gender  
[units: participants]
     
Female     24     21     45  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     29     26     55  



  Outcome Measures

1.  Primary:   Change From Baseline in Depression Symptom Severity at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Robert McNamara
Organization: University of Cincinnati
phone: 513-558-5601
e-mail: robert.mcnamara@uc.edu



Responsible Party: Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00917501     History of Changes
Other Study ID Numbers: Del/McNa OMega 3
MH083924
Study First Received: June 8, 2009
Results First Received: October 26, 2015
Last Updated: May 2, 2016
Health Authority: United States: Food and Drug Administration