Trial Outcomes & Findings for A Double Blind Clinical Trial of DCS for Food Anxiety (NCT NCT01996644)

Results Overview

Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition. Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

Twice a week for two weeks

Results posted on

2018-03-27

Participant Flow

47 participants were enrolled in the study, but only 36 were randomized and given any medication or placebo (i.e., participants completed the assessment portion of the study but did not move to the active experimental portion of the study).

Participant milestones

Participant milestones
Measure	Setraline 250 mg DCS (setraline) Sertaline	Placebo Placebo group
Overall Study STARTED	20	16
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double Blind Clinical Trial of DCS for Food Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Setraline n=20 Participants 250 mg DCS (setraline) versus placebo Sertaline	Placebo n=16 Participants Placebo Group	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.10 years n=5 Participants	24.63 years n=7 Participants	25.44 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	16 participants n=7 Participants	36 participants n=5 Participants
BMI	20.10 kg/m^2 STANDARD_DEVIATION 2.13 • n=5 Participants	20.44 kg/m^2 STANDARD_DEVIATION 1.91 • n=7 Participants	20.25 kg/m^2 STANDARD_DEVIATION 2.09 • n=5 Participants

PRIMARY outcome

Timeframe: Twice a week for two weeks

Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition. Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced.

Outcome measures

Outcome measures
Measure	Setraline n=20 Participants 250 mg DCS (setraline) versus placebo Placebo vs Setraline: Placebo	Placebo n=16 Participants Placebo group Placebo vs Setraline: Placebo	All Combined Setraline and Placebo groups
Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).	52.395 Units on a scale Standard Deviation 5.493	58.983 Units on a scale Standard Deviation 6.141	—

PRIMARY outcome

Timeframe: twice a week for two weeks and at initial assessment

BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome.

Outcome measures

Outcome measures
Measure	Setraline n=20 Participants 250 mg DCS (setraline) versus placebo Placebo vs Setraline: Placebo	Placebo n=16 Participants Placebo group Placebo vs Setraline: Placebo	All Combined Setraline and Placebo groups
Body Mass Index	.385 kg/m^2 Standard Deviation .3	.095 kg/m^2 Standard Deviation .3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Twice during 2 weeks

Population: All combined represents the total number of participants (n=40); however 4 participants withdrew. Analysis utilized data for 36 participants who started in participant flow, thus (n=36).

The Fear of Food Measure (FOFM) was designed to assess three cognitive behavioral components related to mealtime anxiety. All items are rated on a 1 to 7 Likert-type scale ranging from "not at all" to "very much so." Higher values indicate worse outcomes. The first subscale is the anxiety about eating subscale, which was designed to assess trait levels of fear and anxiety surrounding eating and food. This subscale will be measured once before and after the trial (twice in 2 weeks). Each item (8 items totaled, each scored 1-7; max possible score is 56; min possible score is 8) was added for each time point and time points were averaged together for all participants for both time points.

Outcome measures

Outcome measures
Measure	Setraline n=20 Participants 250 mg DCS (setraline) versus placebo Placebo vs Setraline: Placebo	Placebo n=16 Participants Placebo group Placebo vs Setraline: Placebo	All Combined n=36 Participants Setraline and Placebo groups
Fear of Food Measure	19.55 Units on a scale Standard Deviation 5.6	21.22 Units on a scale Standard Deviation 5.8	20.01 Units on a scale Standard Deviation 5.7

Adverse Events

Setraline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cheri Levinson

Washington University

Phone: 5023456483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place