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Treatment of Anxiety and Anorexia Nervosa in Adolescents (TAANA)

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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
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PUFA Placebo Pill
Hide Arm/Group Description

Fish oil for 12 weeks

Fish oil: Participants will take 4 capsules daily

Placebo pills for 12 weeks

Placebo pill: Participants will take 4 capsules daily

Period Title: Overall Study
Started 12 12
Completed 10 8
Not Completed 2 4
Arm/Group Title PUFA Placebo Total
Hide Arm/Group Description Participants randomized to omega-3 PUFA Participants randomized to placebo Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
15.0  (1.3) 14.4  (1.8) 14.7  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
12
 100.0%
12
 100.0%
24
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 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  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 12 participants 24 participants
19.6  (2.0) 18.8  (2.1) 19.2  (2.1)
1.Primary Outcome
Title Medication Side Effects Score
Hide Description At 6 and 12 weeks, medication tolerability was assessed via self-report of nine potential side effects (e.g. diarrhea, burping). Participants were asked whether they experienced these side effects “never, rarely, occasionally, frequently, or very frequently.” Individual responses were assigned a numeric equivalent from 0 to 4, and summed for a total side effect score ranging from 0 to 36. Higher scores indicated greater frequency of side effects and lower medication tolerability.
Time Frame 6 and12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who completed at least a baseline study visit.
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Participants randomized to omega-3 PUFA
Participants randomized to placebo
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: Score on a scale
6 Weeks Number Analyzed 12 participants 10 participants
9.5  (1.7) 6.2  (2.0)
12 Weeks Number Analyzed 10 participants 8 participants
6.4  (1.8) 4.1  (2.0)
2.Secondary Outcome
Title Beck Anxiety Inventory—Trait (BAIT)
Hide Description The BAIT is a 21-item self-report measure of anxiety severity rated on a 4-point Likert scale (0= rarely or never; 3= almost always). It has shown acceptable reliability and validity in an adolescent psychiatric inpatient population. BAIT scores over 26 indicate severe anxiety, scores 16-25 indicate moderate anxiety, scores 8-15 indicate mild anxiety, and scores 0-7 indicate a minimal level of anxiety. We chose to measure trait anxiety to examine beyond meal-related (state) anxiety.
Time Frame Baseline, 6 weeks, and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed a baseline study visit
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Participants randomized to omega-3 PUFA
Participants randomized to placebo
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: Score on a scale
Baseline Number Analyzed 12 participants 12 participants
26.4  (2.8) 19.3  (3.0)
6 Weeks Number Analyzed 12 participants 10 participants
21.9  (2.8) 11  (3.0)
12 Weeks Number Analyzed 10 participants 8 participants
14.9  (3.0) 6.5  (3.3)
3.Other Pre-specified Outcome
Title Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use
Hide Description

At baseline, 6 weeks, and 12 weeks, study participants were asked to collect salivary samples 5 times over a 24 hour period. In addition, participants were asked to wear a 24 hour heart monitor during this same 24 hour interval. Compliance wtth completion of these physiological measures was assessed as follows:

  1. For saliva collection, compliance was assessed by return of 5 full vials of saliva with record of time collected.
  2. For 24 hour heart rate monitor, compliance was assessed by return of monitor with then downloading of data to confirm that the participant wore the device during the specified time interval.
Time Frame Baseline, 6 weeks, and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants completing at least a baseline visit.
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Participants randomized to omega-3 PUFA
Participants randomized to placebo
Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Tolerated Saliva Collection
12
 100.0%
12
 100.0%
Tolerated 24 Hour Heart Rate Monitor
12
 100.0%
12
 100.0%
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PUFA Placebo
Hide Arm/Group Description Participants randomized to omega-3 PUFA Participants randomized to placebo
All-Cause Mortality
PUFA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PUFA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PUFA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/12 (25.00%)      2/12 (16.67%)    
Psychiatric disorders     
Suidical Ideation   2/12 (16.67%)  2 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders     
Rash  [1]  1/12 (8.33%)  1 1/12 (8.33%)  1
Swelling of Eyelid   0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
Rash from EKG lead
Study limitations include small sample size and reliance on self-reported medication adherence.
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
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