Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00525837|
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : May 23, 2011
Last Update Posted : November 28, 2018
This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications.
Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks.
Medication will be provided free of charge.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder Smoking||Drug: fixed dose varenicline Drug: varenicline||Not Applicable|
Outpatient smokers who are depressed despite current stable psychiatric medication regimens will be invited to participate.
They will receive varenicline dosed according to FDA-approved smoking cessation regime; patients will be assessed using QIDS-SR16, snaith-hamilton anhedonia rating scale, SAFTEE and clinical global improvement self-report scales and clinician global improvement scales at the above time intervals.
Concurrent medication, psychiatric and non-psychiatric, will be recorded, as will vital signs (BP, HR, weight) and tobacco use.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
open label varenicline
Drug: fixed dose varenicline
varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.
Other Name: Chantix
up to 1 mg twice daily
Other Name: Chantix
- Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report [ Time Frame: Baseline and every 2 weeks until 8 weeks or study endpoint ]
this is a 16-item self report questionnaire that measures depressive symptoms.
Improvement is reported in change in depressive score
score ranges from 0-27, with higher numbers indicating more severe symptom reporting.
change is calculated by baseline plus/minus the value at the later time point
- Improvement on Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 6-8 weeks ]Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al, 1995). The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14. The SHAPS has adequate construct validity and satisfactory test-retest reliability (ICC=0.70) (Franken et al, 2007). High internal consistency has also been reported (Cronbach's alpha of 0.94) (Franken et al, 2007)
- Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) [ Time Frame: 6-8 weeks ]
Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525837
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Noah S Philip, MD||Butler Hospital|
|Study Director:||Lawrence H Price, MD||Butler Hospital|