Trial Outcomes & Findings for Varenicline in Bipolar Depressed Patients (NCT NCT00813800)

Results Overview

Measured by expired breath in parts per million (ppm)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-01-30

Participant Flow

11 patients were enrolled from the community all with bipolar depression and the desire to stop smoking.

36 patients who were screened did not meet inclusion/exclusion criteria and excluded from participation.

Participant milestones

Participant milestones
Measure	Varenicline Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Overall Study STARTED	11
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Varenicline Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Overall Study Screen Failure after Consent	2
Overall Study Adverse Event	1
Overall Study Worsening of depression	2
Overall Study Physician Decision	1

Baseline Characteristics

Varenicline in Bipolar Depressed Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline n=11 Participants Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Age Continuous	38.8 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Brief Questionnaire of Smoking Urges (QSU-brief)	476 Units on a scale STANDARD_DEVIATION 89.3 • n=5 Participants
Cigarettes (per day)	15.8 Cigarettes STANDARD_DEVIATION 2 • n=5 Participants
Carbon Monoxide Breath Level	20 ppm STANDARD_DEVIATION 4.6 • n=5 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	9.9 Units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
Young Mania Rating Scale (YMRS)	1.9 Units on a scale STANDARD_DEVIATION 0.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intention to Treat (ITT)

Measured by expired breath in parts per million (ppm)

Outcome measures

Outcome measures
Measure	Varenicline n=5 Participants Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Carbon Monoxide Breath Level at 12 Weeks	6 ppm Standard Deviation 2.1

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to Treat (ITT)

MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score \> 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.

Outcome measures

Outcome measures
Measure	Varenicline n=5 Participants Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks	6 Units on a Scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to Treat (ITT)

YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.

Outcome measures

Outcome measures
Measure	Varenicline n=5 Participants Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Young Mania Rating Scale (YMRS) at 12 Weeks	4 Units on a Scale Standard Deviation 1.5

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Varenicline n=9 participants at risk Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Cardiac disorders Elevated blood pressure	11.1% 1/9 • Number of events 1 • 12 weeks per participant
Musculoskeletal and connective tissue disorders Compartmental Syndrome	11.1% 1/9 • Number of events 1 • 12 weeks per participant
Psychiatric disorders Worsening Depression	22.2% 2/9 • Number of events 2 • 12 weeks per participant
General disorders Lack of concentration	11.1% 1/9 • Number of events 1 • 12 weeks per participant

Additional Information

Mark Frye, MD

Mayo Clinic

Phone: 507-255-9391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place