Trial Outcomes & Findings for Treatment of Anxiety and Anorexia Nervosa in Adolescents (NCT NCT01933243)

NCT ID: NCT01933243

Last Updated: 2018-04-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 6 and12 weeks
• Results posted on: 2018-04-23

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	12	12
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Anxiety and Anorexia Nervosa in Adolescents

Baseline characteristics by cohort

Measure	PUFA n=12 Participants Participants randomized to omega-3 PUFA	Placebo n=12 Participants Participants randomized to placebo	Total n=24 Participants Total of all reporting groups
Age, Continuous	15.0 years STANDARD_DEVIATION 1.3 • n=5 Participants	14.4 years STANDARD_DEVIATION 1.8 • n=7 Participants	14.7 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	19.6 kg/m^2 STANDARD_DEVIATION 2.0 • n=5 Participants	18.8 kg/m^2 STANDARD_DEVIATION 2.1 • n=7 Participants	19.2 kg/m^2 STANDARD_DEVIATION 2.1 • n=5 Participants

PRIMARY outcome

Timeframe: 6 and12 weeks

Population: Participants who completed at least a baseline study visit.

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.

Outcome measures

Measure	PUFA n=12 Participants Participants randomized to omega-3 PUFA	Placebo n=12 Participants Participants randomized to placebo
Medication Side Effects Score 6 Weeks	9.5 Score on a scale Standard Error 1.7	6.2 Score on a scale Standard Error 2.0
Medication Side Effects Score 12 Weeks	6.4 Score on a scale Standard Error 1.8	4.1 Score on a scale Standard Error 2.0

SECONDARY outcome

Timeframe: Baseline, 6 weeks, and 12 weeks

Population: All participants who completed a baseline study visit

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.

Outcome measures

Measure	PUFA n=12 Participants Participants randomized to omega-3 PUFA	Placebo n=12 Participants Participants randomized to placebo
Beck Anxiety Inventory-Trait (BAIT) Baseline	26.4 Score on a scale Standard Error 2.8	19.3 Score on a scale Standard Error 3.0
Beck Anxiety Inventory-Trait (BAIT) 6 Weeks	21.9 Score on a scale Standard Error 2.8	11 Score on a scale Standard Error 3.0
Beck Anxiety Inventory-Trait (BAIT) 12 Weeks	14.9 Score on a scale Standard Error 3.0	6.5 Score on a scale Standard Error 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks, and 12 weeks

Population: All participants completing at least a baseline visit.

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.

Outcome measures

Measure	PUFA n=12 Participants Participants randomized to omega-3 PUFA	Placebo n=12 Participants Participants randomized to placebo
Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use Tolerated Saliva Collection	12 Participants	12 Participants
Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use Tolerated 24 Hour Heart Rate Monitor	12 Participants	12 Participants

Adverse Events

PUFA

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PUFA n=12 participants at risk Participants randomized to omega-3 PUFA	Placebo n=12 participants at risk Participants randomized to placebo
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Number of events 1 • 12 weeks	8.3% 1/12 • Number of events 1 • 12 weeks
Psychiatric disorders Suidical Ideation	16.7% 2/12 • Number of events 2 • 12 weeks	8.3% 1/12 • Number of events 1 • 12 weeks
Skin and subcutaneous tissue disorders Swelling of Eyelid	0.00% 0/12 • 12 weeks	8.3% 1/12 • Number of events 1 • 12 weeks

Additional Information

Andrea Bonny

Nationwide Children's Hospital

Phone: 614-722-2458

Email: andrea.bonny@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place