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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00288574
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 93
• Location: 1
• Arms: 2
• Duration (Months): 64
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of people who have been treated for AN.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa; Eating Disorders	Drug: Fluoxetine; Drug: Placebo	Phase 4

Detailed Description

Anorexia nervosa (AN), a type of eating disorder, is a serious psychiatric illness that is characterized by an extreme loss of appetite. People with AN view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. Signs of the disorder include unusual eating habits, such as avoiding food and meals, picking out a few foods and eating them in small quantities, or carefully weighing and portioning food. Some people with AN fully recover after a single episode, some have a fluctuating pattern of weight gain and relapse, and others experience a chronic course of illness over many years. Effective drugs to treat the disorder are lacking. In addition, most past research has examined the effect of medications during the initial phase of treatment, a time when AN patients may not respond to medication because of the acute effects of starvation. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that is commonly used to treat depression. This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of AN and enhancing the psychosocial and behavioral recovery of women who have already been treated for AN.

Participants in this double-blind study will be recruited immediately following completion of a treatment program for AN, in which they maintained a body mass index (BMI) of at least 19 kg/m2 for two weeks. Upon study entry, participants will be randomly assigned to receive either fluoxetine or placebo for 12 months. Participants will begin receiving medication one week prior to discharge from the hospital in which they received care for AN. Medication doses will be increased up to a target dose of 60 mg per day, and will not exceed 80 mg per day. Participants will receive 50 sessions of cognitive-behavioral therapy, lasting approximately 45 minutes each and occurring twice weekly for the first month following discharge from the hospital. After the first month, therapy sessions will occur once weekly until Month 9 and then every other week until Month 12. Participants will also report to the study site to meet with a psychiatrist once a week for the first month following discharge and then every other week for the remainder of the study. General medical status, evidence of AN relapse, medication dose, and side effects will be assessed at these visits. Upon completing treatment, follow-up telephone calls will occur at Months 15 and 21, and follow-up visits will be held at Months 18 and 24. Psychopathology associated with AN, including concern with weight and shape, depressive symptoms, anxiety, and obsessive behavior, will be assessed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Fluoxetine After Weight Restoration in Anorexia Nervosa
• Study Start Date: Jan 1, 2000
• Actual Primary Completion Date: May 1, 2005
• Actual Study Completion Date: May 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fluoxetine fluoxetine up to 80 mg per day	Drug: Fluoxetine
Placebo Comparator: Placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients Remaining in Study at 1 Year [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.

Secondary Outcome Measures

1. Change in Weight Per Month During Treatment [12 months]

2. Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI) [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.

3. Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI) [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.

4. Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES). [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.

5. Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). [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.

6. Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale. [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.

7. Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale. [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.

8. Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale. [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.

9. Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale. [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.

10. Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Meets DSM-IV criteria for anorexia nervosa (except the requirement for amenorrhea)

• Successfully completed treatment at one of the study sites in an inpatient or day-program setting immediately prior to study entry (BMI remained at least 19 kg/m2 for two weeks)

Exclusion Criteria:

• Currently taking any medications other than occasional lorazepam or zopiclone for anxiety or sleep disturbance

• Previous serious adverse reactions to fluoxetine (e.g., allergy)

• Currently at risk for suicide

• Any medical condition requiring treatment with other psychotropic medication (except the occasional use of anti-anxiety medication)

• Pregnant

• Any serious medical illness besides the eating disorder

• History of continuous illness (at a low weight with no periods of remission or return to normal functioning for more than 15 years)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute/Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: B. Timothy Walsh, MD, New York State Psychiatric Institute/Columbia University Medical Center
• Principal Investigator: Allan Kaplan, MD, Toronto General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00288574
• Other Study ID Numbers: #4703R; R01MH060271; R01MH060336; DSIR AT-P
• First Posted: Feb 8, 2006
• Last Update Posted: Dec 13, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by New York State Psychiatric Institute: Depression
• Additional relevant MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa; Fluoxetine

Study Results

Participant Flow

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day Fluoxetine	Placebo group
Period Title: Overall Study
STARTED	49	44
COMPLETED	49	44
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fluoxetine	Placebo	Total
Arm/Group Description	fluoxetine up to 80 mg per day Fluoxetine	Placebo group	Total of all reporting groups
Overall Participants	49	44	93
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	49 100%	44 100%	93 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.4 (4.46)	24.2 (4.52)	23 (4.6)
Sex: Female, Male (Count of Participants)
Female	49 100%	44 100%	93 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	26 53.1%	19 43.2%	45 48.4%
Canada	23 46.9%	25 56.8%	48 51.6%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients Remaining in Study at 1 Year
Description	The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining > 85% Ideal Body Weight.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day Fluoxetine	Placebo group
Measure Participants	49	44
Number [proportion of participants]	0.265 0.5%	0.315 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	The proportion of patients successfully completing the trial in the fluoxetine and placebo groups was compared using the chi-squared statistic.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.57
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Change in Weight Per Month During Treatment
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	Placebo
Measure Participants	49	44
Mean (Standard Error) [kg per month]	-1.94 (0.51)	-2.14 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment in body weight, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.75
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	-0.70 (0.12)	-0.22 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment of BDI in fluoxetine versus placebo groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	0.12 (0.25)	0.20 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment in BDI, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	0.12 (0.08)	0.07 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment in RSES, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [percentage of maximum possible score]	0.23 (0.23)	0.31 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment in Q-LES-Q, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

7. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	-0.24 (0.09)	-0.81 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment in Drive for Thinness subscale, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

8. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	-0.11 (0.07)	0.035 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment in Bulimia subscale, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

9. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	-0.24 (0.09)	-0.26 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment on Body Dissatisfaction subscale, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.86
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

10. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	-0.037 (0.03)	0.05 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment on Perfectionism subscale, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.
	Method	Mixed Models Analysis
	Comments

11. Secondary Outcome

Title	Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS)
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Placebo
Arm/Group Description	fluoxetine up to 80 mg per day	placebo to match fluoxetine
Measure Participants	49	44
Mean (Standard Error) [units on a scale]	-0.18 (0.13)	0.028 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoxetine, Placebo
	Comments	Random effects regression analysis of change during treatment on the YBC-EDS, in fluoxetine vs placebo groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	Mixed Models Analysis
	Comments	Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.

Adverse Events

Adverse Event Reporting Description	Approximately weekly clinician interview over one year
Arm/Group Title	Fluoxetine		Placebo
Arm/Group Description	fluoxetine up to 80 mg per day Fluoxetine		Placebo Medication
All Cause Mortality
	Fluoxetine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluoxetine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/49 (2%)		0/44 (0%)
Psychiatric disorders
suicide attempt	1/49 (2%)	1	0/44 (0%)	0
Other (Not Including Serious) Adverse Events
	Fluoxetine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.