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Trial record 1 of 10 for:    OMEGA-3 MANIA
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Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania (R34)

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ClinicalTrials.gov Identifier: NCT00917501
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : June 9, 2016
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robert McNamara, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Mania
Interventions Drug: OMega 3
Drug: Placebo
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Omega-3
Hide Arm/Group Description Olive oil - 3 capsules/day Fish oil - 3 capsules/day
Period Title: Overall Study
Started 29 26
Completed 21 21
Not Completed 8 5
Reason Not Completed
Lost to Follow-up             4             1
Withdrawal by Subject             3             1
Lack of Efficacy             1             2
trouble swollowing capsules             0             1
Arm/Group Title Placebo Omega-3 Total
Hide Arm/Group Description Olive oil - 3 capsules/day Fish oil - 3 capsules/day Total of all reporting groups
Overall Number of Baseline Participants 29 26 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 26 participants 55 participants
13.4  (3.3) 13  (4.5) 13.2  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 26 participants 55 participants
Female
24
  82.8%
21
  80.8%
45
  81.8%
Male
5
  17.2%
5
  19.2%
10
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 26 participants 55 participants
29 26 55
1.Primary Outcome
Title Change From Baseline in Depression Symptom Severity at 12 Weeks
Hide Description Change in Children’s Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Omega-3
Hide Arm/Group Description:
Olive oil - 3 capsules/day
Fish oil - 3 capsules/day
Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: Total score on CDRS-R
18  (9.7) 17.7  (11)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Omega-3
Hide Arm/Group Description Olive oil - 3 capsules/day Fish oil - 3 capsules/day
All-Cause Mortality
Placebo Omega-3
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Omega-3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Omega-3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      8/26 (30.77%)    
General disorders     
Muscle Cramps *  0/29 (0.00%)  0 8/26 (30.77%)  10
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Robert McNamara
Organization: University of Cincinnati
Phone: 513-558-5601
EMail: robert.mcnamara@uc.edu
Layout table for additonal information
Responsible Party: Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00917501     History of Changes
Other Study ID Numbers: Del/McNa OMega 3
MH083924
First Submitted: June 8, 2009
First Posted: June 10, 2009
Results First Submitted: October 26, 2015
Results First Posted: June 9, 2016
Last Update Posted: November 13, 2019