Trial · NCT01933243

Treatment of Anxiety and Anorexia Nervosa in Adolescents

NCT01933243, Phase 2, Completed, Andrea Bonny; results first posted 2018-04-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Anxiety and Anorexia Nervosa in Adolescents. Trials, record NCT01933243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01933243

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment of Anxiety and Anorexia Nervosa in Adolescents
NCT number: NCT01933243
Status: Completed
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Andrea Bonny
Conditions: Anxiety, Anorexia Nervosa
Interventions: Fish oil, Placebo pill
First posted: 2013-09-02
Last updated: 2018-04-23
Results first posted: 2018-04-23
Limitations and caveats: Study limitations include small sample size and reliance on self-reported medication adherence.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Medication Side Effects Score	6 and12 weeks	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.
Secondary	Beck Anxiety Inventory-Trait (BAIT)	Baseline, 6 weeks, and 12 weeks	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.
Other	Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use	Baseline, 6 weeks, and 12 weeks	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Medication Side Effects Score	6 and12 weeks	Participants who completed at least a baseline study visit.	Score on a scale	MEAN
SECONDARY	Beck Anxiety Inventory-Trait (BAIT)	Baseline, 6 weeks, and 12 weeks	All participants who completed a baseline study visit	Score on a scale	MEAN
OTHER_PRE_SPECIFIED	Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use	Baseline, 6 weeks, and 12 weeks	All participants completing at least a baseline visit.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Medication Side Effects Score	PUFA	6 Weeks	9.5	Standard Error 1.7	Score on a scale
Medication Side Effects Score	Placebo	6 Weeks	6.2	Standard Error 2.0	Score on a scale
Medication Side Effects Score	PUFA	12 Weeks	6.4	Standard Error 1.8	Score on a scale
Medication Side Effects Score	Placebo	12 Weeks	4.1	Standard Error 2.0	Score on a scale
Beck Anxiety Inventory-Trait (BAIT)	PUFA	Baseline	26.4	Standard Error 2.8	Score on a scale
Beck Anxiety Inventory-Trait (BAIT)	Placebo	Baseline	19.3	Standard Error 3.0	Score on a scale
Beck Anxiety Inventory-Trait (BAIT)	PUFA	6 Weeks	21.9	Standard Error 2.8	Score on a scale
Beck Anxiety Inventory-Trait (BAIT)	Placebo	6 Weeks	11	Standard Error 3.0	Score on a scale
Beck Anxiety Inventory-Trait (BAIT)	PUFA	12 Weeks	14.9	Standard Error 3.0	Score on a scale
Beck Anxiety Inventory-Trait (BAIT)	Placebo	12 Weeks	6.5	Standard Error 3.3	Score on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PUFA	12
Overall Study	STARTED	Placebo Pill	12
Overall Study	COMPLETED	PUFA	10
Overall Study	COMPLETED	Placebo Pill	8
Overall Study	NOT COMPLETED	PUFA	2
Overall Study	NOT COMPLETED	Placebo Pill	4

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Rash	Skin and subcutaneous tissue disorders	PUFA	1	12	1
other	Rash	Skin and subcutaneous tissue disorders	Placebo	1	12	1
other	Suidical Ideation	Psychiatric disorders	PUFA	2	12	2
other	Suidical Ideation	Psychiatric disorders	Placebo	1	12	1
other	Swelling of Eyelid	Skin and subcutaneous tissue disorders	PUFA	0	12	0
other	Swelling of Eyelid	Skin and subcutaneous tissue disorders	Placebo	1	12	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PUFA	0	12
Total, all-cause mortality	Placebo	0	12
Total, other adverse events	PUFA	3	12
Total, other adverse events	Placebo	2	12
Total, serious adverse events	PUFA	0	12
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
PUFA vs Placebo: deaths from any cause	Trial comparisons
PUFA vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01933243

GET https://conductscience.org/api/trials/v1/NCT01933243/registered

API reference For AI assistants