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Trial record 99 of 2664 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT00578669
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Nicotine Dependence
Depression
Interventions Drug: Fluoxetine
Drug: Dextrose
Enrollment 206
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequential Fluoxetine Sequential Placebo
Hide Arm/Group Description

Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.

Fluoxetine was used once daily for 16 weeks.

Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Dextrose was used once daily for 16 weeks

Period Title: Overall Study
Started 107 99
Completed 107 99
Not Completed 0 0
Arm/Group Title Sequential Placebo Sequential Fluoxetine Total
Hide Arm/Group Description

Participants received placebo medication, dextrose, that was begun 8 weeks prior to and extended throughout the brief, behavioral standard smoking cessation treatment that included transdermal nicotine patch.

The placebo medication (dextrose) was taken once daily for 16 weeks.

Participants received fluoxetine medication, 20 mg, that was begun 8 weeks prior to and extended throughout the brief, behavioral standard smoking cessation treatment that included transdermal nicotine patch.

The fluoxetine medication (20 mg) was taken once daily for 16 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 99 107 206
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 107 participants 206 participants
44.05  (11.40) 43.07  (10.97) 43.54  (11.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
Female
48
  48.5%
51
  47.7%
99
  48.1%
Male
51
  51.5%
56
  52.3%
107
  51.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
Hispanic or Latino
1
   1.0%
2
   1.9%
3
   1.5%
Not Hispanic or Latino
98
  99.0%
105
  98.1%
203
  98.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
American Indian or Alaska Native
4
   4.0%
0
   0.0%
4
   1.9%
Asian
0
   0.0%
2
   1.9%
2
   1.0%
Native Hawaiian or Other Pacific Islander
1
   1.0%
0
   0.0%
1
   0.5%
Black or African American
5
   5.1%
6
   5.6%
11
   5.3%
White
89
  89.9%
99
  92.5%
188
  91.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 99 participants 107 participants 206 participants
99 107 206
Cigarettes smoked per day (past month)  
Mean (Standard Deviation)
Unit of measure:  Cigarettes
Number Analyzed 99 participants 107 participants 206 participants
21.07  (9.03) 20.96  (10.33) 21.01  (9.7)
Fagerstrom Test for Nicotine Dependence (FTND)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 99 participants 107 participants 206 participants
5.40  (2.37) 5.90  (1.74) 5.66  (2.08)
[1]
Measure Description: Scale can be scored on a range of 0 - 10. Higher scores signify greater levels of nicotine dependence.
Center for Epidemiologic Studies - Depression (CES-D) scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 99 participants 107 participants 206 participants
9.64  (8.53) 9.90  (8.14) 9.77  (8.31)
[1]
Measure Description: CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.
Center for Epidemiologic Studies - Depression (CES-D) > 16   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
15
  15.2%
21
  19.6%
36
  17.5%
[1]
Measure Description: CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.
Recurrent major depressive disorder (MDD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
18
  18.2%
16
  15.0%
34
  16.5%
Single major depressive disorder (MDD) episode  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
7
   7.1%
7
   6.5%
14
   6.8%
1.Primary Outcome
Title Number of Participants Achieving Smoking Abstinence
Hide Description 7-day point prevalence abstinence
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sequential Fluoxetine Sequential Placebo
Hide Arm/Group Description:

Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.

Fluoxetine was used once daily for 16 weeks.

Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Dextrose was used once daily for 16 weeks

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
24
  22.4%
18
  18.2%
2.Secondary Outcome
Title Self-reported Depressive Symptoms
Hide Description Self-reported depressive symptoms based on the Center for Epidemiologic Studies-Depression (CES-D) scale. CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sequential Fluoxetine Sequential Placebo
Hide Arm/Group Description:

Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.

Fluoxetine was used once daily for 16 weeks.

Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Dextrose was used once daily for 16 weeks

Overall Number of Participants Analyzed 107 99
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.9  (8.14) 9.64  (8.53)
Time Frame Adverse event data were collected over a one year period.
Adverse Event Reporting Description Definitions of adverse event and/or serious adverse event do not differ from the clinicaltrials.gov definitions.
 
Arm/Group Title Sequential Fluoxetine Sequential Placebo
Hide Arm/Group Description

Sequential antidepressant pharmacotherapy with (20mg) fluoxetine, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Fluoxetine: 20mg once daily for 16 weeks

Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Dextrose: Once daily for 16 weeks

All-Cause Mortality
Sequential Fluoxetine Sequential Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)      0/99 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sequential Fluoxetine Sequential Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/107 (0.00%)      0/99 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sequential Fluoxetine Sequential Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/107 (0.93%)      0/99 (0.00%)    
Gastrointestinal disorders     
Frequent bowel movements   1/107 (0.93%)  1 0/99 (0.00%)  0
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Dr. Richard A. Brown
Organization: UT Austin School of Nursing
Phone: 512-471-8584
Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00578669     History of Changes
Other Study ID Numbers: PHI0710-002
1R01DA023190 ( U.S. NIH Grant/Contract )
First Submitted: December 19, 2007
First Posted: December 21, 2007
Results First Submitted: August 9, 2018
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018