Trial Outcomes & Findings for Omega 3 FA Supplements as Augmentation in the Treatment of Depression (NCT NCT01803711)

NCT ID: NCT01803711

Last Updated: 2017-12-27

Results Overview

Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

6 participants

Primary outcome timeframe

12 weeks from baseline

Results posted on

2017-12-27

Participant Flow

A total of 30 subjects underwent phone screening. Of these, a total of 6 subjects were consented and 5 met study eligibility criteria.

One subject who was consented did not meet the threshold for depression symptomatology during screening as determined by the Hospital Anxiety and Depression Scale.

Participant milestones

Participant milestones
Measure	Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period Desvenlafaxine Omega 3 Fatty acids 2 subjects were randomized to this group	Desvenlafaxine + Placebo (for Omega 3 FA Supplement) Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period Desvenlafaxine Placebo (for Omega 3 fatty acid supplement) 3 subjects were randomized to this group
Overall Study STARTED	2	3
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period Desvenlafaxine Omega 3 Fatty acids 2 subjects were randomized to this group	Desvenlafaxine + Placebo (for Omega 3 FA Supplement) Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period Desvenlafaxine Placebo (for Omega 3 fatty acid supplement) 3 subjects were randomized to this group
Overall Study Adverse Event	1	1

Baseline Characteristics

Omega 3 FA Supplements as Augmentation in the Treatment of Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desvenlafaxine + Omega 3 FA Supplement n=2 Participants Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period Desvenlafaxine Omega 3 Fatty acids Age range: 53 to 66 years Gender: 1 male and 1 female	Desvenlafaxine + Placebo (for Omega 3 FA Supplement) n=3 Participants Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period Desvenlafaxine Placebo (for Omega 3 fatty acid supplement) Age range: 53 to 66 years \] Gender: 1 male and 2 females	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic/Latino	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks from baseline

Population: Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks from baseline

Population: Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks from baseline

Population: Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks from baseline

Population: Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks from baseline

Population: Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks from baseline

Population: Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Outcome measures

Outcome data not reported

Adverse Events

Desvenlafaxine + Omega 3 FA Supplement

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Desvenlafaxine + Placebo (for Omega 3 FA Supplement)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Desvenlafaxine + Omega 3 FA Supplement n=2 participants at risk Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period Desvenlafaxine Omega 3 Fatty acids 2 subjects were randomized to this group	Desvenlafaxine + Placebo (for Omega 3 FA Supplement) n=3 participants at risk Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period Desvenlafaxine Placebo (for Omega 3 fatty acid supplement) 3 subjects were randomized to this group
Gastrointestinal disorders diarrhea	50.0% 1/2 • Number of events 1	0.00% 0/3
Nervous system disorders Memory problems	0.00% 0/2	33.3% 1/3 • Number of events 1

Additional Information

Jayesh Kamath MD PhD

UConn Health Center

Phone: 8606796727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place