Trial Outcomes & Findings for Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa (NCT NCT00288574)

Results Overview

The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining \> 85% Ideal Body Weight.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

93 participants

Primary outcome timeframe

12 months

Results posted on

2017-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Fluoxetine fluoxetine up to 80 mg per day Fluoxetine	Placebo Placebo group
Overall Study STARTED	49	44
Overall Study COMPLETED	49	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=93 Participants	44 Participants n=4 Participants	93 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	22.4 years STANDARD_DEVIATION 4.46 • n=93 Participants	24.2 years STANDARD_DEVIATION 4.52 • n=4 Participants	23 years STANDARD_DEVIATION 4.6 • n=27 Participants
Sex: Female, Male Female	49 Participants n=93 Participants	44 Participants n=4 Participants	93 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	26 participants n=93 Participants	19 participants n=4 Participants	45 participants n=27 Participants
Region of Enrollment Canada	23 participants n=93 Participants	25 participants n=4 Participants	48 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining \> 85% Ideal Body Weight.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Proportion of Patients Remaining in Study at 1 Year	0.265 proportion of participants	0.315 proportion of participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change in Weight Per Month During Treatment	-1.94 kg per month Standard Error 0.51	-2.14 kg per month Standard Error 0.33

SECONDARY outcome

Timeframe: 12 months

The Beck Anxiety Inventory is a 21 question self-report measure of anxiety symptoms during the past week. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)	-0.70 units on a scale Standard Error 0.12	-0.22 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: 12 months

The Beck Depression Inventory-II is a 21 question self-report measure of depressive symptoms. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms.Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)	0.12 units on a scale Standard Error 0.25	0.20 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: 12 months

The RSES is a 10 item self-report measure of self-esteem. Possible scores range from 0 - 30, with lower scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).	0.12 units on a scale Standard Error 0.08	0.07 units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 12 months

The Q-LES-Q is a 93 item self-report measure of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. Each of the 93 items is scored on a five-point scale, and the total score is converted to a percentage of the maximum score possible. The range is therefore from 0 to 100, with a higher score indicating greater enjoyment or satisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).	0.23 percentage of maximum possible score Standard Error 0.23	0.31 percentage of maximum possible score Standard Error 0.18

SECONDARY outcome

Timeframe: 12 months

The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Drive for Thinness subscale is comprised of seven items indicating excessive concern with dieting, preoccupation with weight and entrenchment in an extreme pursuit of thinness. Possible scores range from 0 to 21, with higher scores indicating greater Drive for Thinness. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale.	-0.24 units on a scale Standard Error 0.09	-0.81 units on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: 12 months

The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Bulimia subscale is comprised of seven items indicating the tendency towards episodes of uncontrollable overeating (binge eating). Possible scores range from 0 to 21, with higher scores indicating greater tendency. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale.	-0.11 units on a scale Standard Error 0.07	0.035 units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 12 months

The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Body Dissatisfaction subscale is comprised of nine items indicating the belief that parts of the body are too large. Possible scores range from 0 to 27, with higher scores indicating greater dissatisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale.	-0.24 units on a scale Standard Error 0.09	-0.26 units on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: 12 months

The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Perfectionism subscale is comprised of six items Indicating excessive personal expectations for superior achievement. Possible scores range from 0 to 18, with higher scores indicating greater expectations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale.	-0.037 units on a scale Standard Error 0.03	0.05 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: 12 months

The YBC-EDS is an eight item, clinician-rated instrument assessing eating related preoccupations and/or rituals. Possible scores range from 0 to 32, with higher scores indicating greater preoccupations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.

Outcome measures

Outcome measures
Measure	Fluoxetine n=49 Participants fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 Participants Placebo group
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS)	-0.18 units on a scale Standard Error 0.13	0.028 units on a scale Standard Error 0.13

Adverse Events

Fluoxetine

Serious events: 1 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

Serious adverse events
Measure	Fluoxetine n=49 participants at risk fluoxetine up to 80 mg per day Fluoxetine	Placebo n=44 participants at risk Placebo Medication
Psychiatric disorders suicide attempt	2.0% 1/49 • Number of events 1 Approximately weekly clinician interview over one year	0.00% 0/44 Approximately weekly clinician interview over one year

Other adverse events

Adverse event data not reported

Additional Information

BT Walsh, MD

NYSPI

Phone: 646-774-8066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place