Trial Outcomes & Findings for Influenza Challenge in Mood Disorders (NCT NCT02415166)

Results Overview

Outcome data were not collected. This was a failed study as all participants, including those who were putatively vaccine-naive had antibodies to influenza at baseline and therefore the original hypothesis could not be tested. The study was terminated.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

ONE MONTH

Results posted on

2018-01-23

Participant Flow

The study was terminated after the recruitment of six participants

Participant milestones

Participant milestones
Measure	VACCINE MDD SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M. INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER	PLACEBO MDD SALINE (0.5ML) DELIVERED I.M. NaCl-saline placebo: placebo	VACCINE HC SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M. INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER	PLACEBO HC SALINE (0.5ML) DELIVERED I.M. NaCl-saline placebo: placebo
Overall Study STARTED	6	0	0	0
Overall Study COMPLETED	6	0	0	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Influenza Challenge in Mood Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VACCINE MDD n=6 Participants SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M. INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER	PLACEBO MDD SALINE (0.5ML) DELIVERED I.M. NaCl-saline placebo: placebo	VACCINE HC SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M. INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER	PLACEBO HC SALINE (0.5ML) DELIVERED I.M. NaCl-saline placebo: placebo	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	—	—	—	6 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Age, Continuous	35 years STANDARD_DEVIATION 6 • n=5 Participants	—	—	—	35 years STANDARD_DEVIATION 6 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	—	—	—	4 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	—	—	2 Participants n=21 Participants
Region of Enrollment United States	6 participants n=5 Participants	—	—	—	6 participants n=21 Participants

PRIMARY outcome

Timeframe: ONE MONTH

Population: Unmedicated outpatients with major depressive disorder. Outcome data not collected.

Outcome data were not collected. This was a failed study as all participants, including those who were putatively vaccine-naive had antibodies to influenza at baseline and therefore the original hypothesis could not be tested. The study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: ONE MONTH

Population: Unmedicated participants with major depressive disorder. Data were not collected.

Data not collected.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 DAYS

Population: Data not analyzed

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 DAYS

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 DAYS

Outcome measures

Outcome data not reported

Adverse Events

VACCINE MDD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PLACEBO MDD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VACCINE HC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PLACEBO HC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Savitz

LaurateInstitute

Phone: 918 502 5104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place