Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 89 for:    DESVENLAFAXINE

Omega 3 FA Supplements as Augmentation in the Treatment of Depression

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: NCT01803711
Recruitment Status : Terminated (Lack of recruitment and no resources)
First Posted : March 4, 2013
Results First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depression
Cancer
Diabetes
Cardiovascular Diseases
Interventions Drug: Desvenlafaxine
Dietary Supplement: Omega 3 Fatty acids
Drug: Placebo (for Omega 3 fatty acid supplement)
Enrollment 6
Recruitment Details A total of 30 subjects underwent phone screening. Of these, a total of 6 subjects were consented and 5 met study eligibility criteria.
Pre-assignment Details One subject who was consented did not meet the threshold for depression symptomatology during screening as determined by the Hospital Anxiety and Depression Scale.
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 2 3
Completed 1 2
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement) Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
  66.7%
4
  80.0%
>=65 years
0
   0.0%
1
  33.3%
1
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
1
  50.0%
2
  66.7%
3
  60.0%
Male
1
  50.0%
1
  33.3%
2
  40.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Non-Hispanic/Latino Number Analyzed 2 participants 3 participants 5 participants
2 3 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title Hospital Anxiety and Depression Scale
Hide Description Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.
Time Frame 12 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description:

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

Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Placebo (for Omega 3 fatty acid supplement)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description [Not Specified]
Time Frame 12 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Short Form Health Survey (SF-12)
Hide Description [Not Specified]
Time Frame 12 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Visual Analog Scale for Energy (VAS-E)
Hide Description [Not Specified]
Time Frame 12 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Visual Analog Scale for Pain (VAS-P)
Hide Description [Not Specified]
Time Frame 12 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Leeds Sleep Evaluation Questionnaire (LSEQ)
Hide Description [Not Specified]
Time Frame 12 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Hide Arm/Group Description

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 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

All-Cause Mortality
Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Desvenlafaxine + Omega 3 FA Supplement Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      1/3 (33.33%)    
Gastrointestinal disorders     
diarrhea * [1]  1/2 (50.00%)  1 0/3 (0.00%)  0
Nervous system disorders     
Memory problems * [2]  0/2 (0.00%)  0 1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Stomach upsets
[2]
Memory problems
Due to very low enrollment in both arms, only descriptive analyses was completed for both arms
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jayesh Kamath MD PhD
Organization: UConn Health Center
Phone: 8606796727
EMail: jkamath@uchc.edu
Layout table for additonal information
Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT01803711     History of Changes
Other Study ID Numbers: OmegaDVS
First Submitted: February 28, 2013
First Posted: March 4, 2013
Results First Submitted: April 13, 2017
Results First Posted: December 27, 2017
Last Update Posted: December 27, 2017