Trials Sponsors Conditions Drugs Pricing

Conditions

Anorexia Nervosa Anxiety

Keywords

AnxietyAnorexia nervosaAdolescentsFish oil

Outcome Measures

Primary Outcomes (1)

Medication Side Effects Score
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.
6 and12 weeks

Secondary Outcomes (1)

Beck Anxiety Inventory-Trait (BAIT)
Baseline, 6 weeks, and 12 weeks

Other Outcomes (1)

Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use
Baseline, 6 weeks, and 12 weeks

Study Arms (2)

Fish oil

EXPERIMENTAL

Fish oil for 12 weeks

Drug: Fish oil

Placebo pill

PLACEBO COMPARATOR

Placebo pills for 12 weeks

Drug: Placebo pill

Interventions

Fish oilDrug

Participants will take 4 capsules daily

Also known as: ProEPA Xtra soft gel capsules, Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg)

Fish oil

Placebo pillDrug

Participants will take 4 capsules daily

Also known as: soybean oil placebo capsules

Eligibility Criteria

Age12 Years - 21 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Females admitted to Nationwide Children's Hospital Eating Disorder Partial Hospitalization Program

You may not qualify if:

Sponsors & Collaborators

Andrea Bonny
Otherlead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

MeSH Terms

Conditions

Anxiety DisordersAnorexia Nervosa

Interventions

Fish OilsEicosapentaenoic AcidDocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Mental DisordersFeeding and Eating Disorders

Intervention Hierarchy (Ancestors)

OilsLipidsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFats

Limitations and Caveats

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

Results Point of Contact

Title: Andrea Bonny
Organization: Nationwide Children's Hospital

Study Officials

Andrea Bonny, MD
Nationwide Children's Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

August 9, 2013

First Posted

September 2, 2013

Study Start

August 2013

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Fish oil

Placebo pill

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations