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Treatment of Anxiety and Anorexia Nervosa in Adolescents (TAANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01933243
Recruitment Status : Completed
First Posted : September 2, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Bonny, Nationwide Children's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anxiety
Anorexia Nervosa
Interventions: Drug: Fish oil
Drug: Placebo pill

  Participant Flow

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
No text entered.

Reporting Groups
  Description
PUFA

Fish oil for 12 weeks

Fish oil: Participants will take 4 capsules daily

Placebo Pill

Placebo pills for 12 weeks

Placebo pill: Participants will take 4 capsules daily


Participant Flow:   Overall Study
    PUFA   Placebo Pill
STARTED   12   12 
COMPLETED   10   8 
NOT COMPLETED   2   4 



  Baseline Characteristics

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
PUFA Participants randomized to omega-3 PUFA
Placebo Participants randomized to placebo
Total Total of all reporting groups

Baseline Measures
   PUFA   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.0  (1.3)   14.4  (1.8)   14.7  (1.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12 100.0%      12 100.0%      24 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      2  16.7%      2   8.3% 
White      12 100.0%      10  83.3%      22  91.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 19.6  (2.0)   18.8  (2.1)   19.2  (2.1) 


  Outcome Measures

1.  Primary:   Medication Side Effects Score   [ Time Frame: 6 and12 weeks ]

2.  Secondary:   Beck Anxiety Inventory—Trait (BAIT)   [ Time Frame: Baseline, 6 weeks, and 12 weeks ]

3.  Other Pre-specified:   Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use   [ Time Frame: Baseline, 6 weeks, and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Study limitations include small sample size and reliance on self-reported medication adherence.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrea Bonny
Organization: Nationwide Children's Hospital
phone: 614-722-2458
e-mail: andrea.bonny@nationwidechildrens.org



Responsible Party: Andrea Bonny, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01933243     History of Changes
Other Study ID Numbers: TAANA-287112
First Submitted: August 9, 2013
First Posted: September 2, 2013
Results First Submitted: October 11, 2017
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018