Omega 3 FA Supplements as Augmentation in the Treatment of Depression

• Sponsor: UConn Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01803711
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes).

Condition or Disease	Intervention/Treatment	Phase
Major Depression; Cancer; Diabetes; Cardiovascular Diseases	Drug: Desvenlafaxine; Dietary Supplement: Omega 3 Fatty acids; Drug: Placebo (for Omega 3 fatty acid supplement)	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness.
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Desvenlafaxine; Other Names: Pristiq ; Dietary Supplement: Omega 3 Fatty acids
Active Comparator: Desvenlafaxine + Placebo (for Omega 3 FA supplement) Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period	Drug: Desvenlafaxine; Other Names: Pristiq ; Drug: Placebo (for Omega 3 fatty acid supplement)

Outcome Measures

Primary Outcome Measures

1. Hospital Anxiety and Depression Scale [12 weeks from baseline]

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

Secondary Outcome Measures

1. Montgomery-Asberg Depression Rating Scale (MADRS) [12 weeks from baseline]

2. Short Form Health Survey (SF-12) [12 weeks from baseline]

3. Visual Analog Scale for Energy (VAS-E) [12 weeks from baseline]

4. Visual Analog Scale for Pain (VAS-P) [12 weeks from baseline]

5. Leeds Sleep Evaluation Questionnaire (LSEQ) [12 weeks from baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older

• Diagnosed with depression and have cardiovascular disease, diabetes or cancer.

• Able to provide written informed consent prior to initiation of any study-related procedures.

• Able to understand and comply with the requirements of the study.

Exclusion Criteria:

• Hospitalized patients or psychotherapy for depression begun within 4 weeks.

• Patients with medically reversible causes of depression (e.g. hypothyroidism).

• Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator

• Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.

• Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study

• Patients with currently active or with significant history of other clinically significant psychiatric disorders such as bipolar disorder, schizophrenia etc.

• Pregnant patients, breastfeeding or those planning to become pregnant during the study.

• Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment in the study, including known or suspect history of allergy to fish oil, fish or desvenlafaxine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Connecticut Health Center	Farmington	Connecticut	United States	06030

Sponsors and Collaborators

• UConn Health

Investigators

• Principal Investigator: Jayesh Kamath, MD PhD, UConn Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UConn Health
• ClinicalTrials.gov Identifier: NCT01803711
• Other Study ID Numbers: OmegaDVS
• First Posted: Mar 4, 2013
• Last Update Posted: Dec 27, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by UConn Health: Omega 3 fatty acid; Fish oil; Depression; cancer; diabetes; high blood pressure; cardiovascular
• Additional relevant MeSH terms: Cardiovascular Diseases; Depression; Depressive Disorder; Desvenlafaxine Succinate

Study Results

Participant Flow

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 Detail	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)
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

Baseline Characteristics

Arm/Group Title	Desvenlafaxine + Omega 3 FA Supplement	Desvenlafaxine + Placebo (for Omega 3 FA Supplement)	Total
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 Participants	2	3	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	2 66.7%	4 80%
>=65 years	0 0%	1 33.3%	1 20%
Sex: Female, Male (Count of Participants)
Female	1 50%	2 66.7%	3 60%
Male	1 50%	1 33.3%	2 40%
Race/Ethnicity, Customized (participants) [Number]
White Non-Hispanic/Latino	2 100%	3 100%	5 100%
Region of Enrollment (participants) [Number]
United States	2 100%	3 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Hospital Anxiety and Depression Scale
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

Outcome Measure Data

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)
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)
Measure Participants	0	0

2. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame	12 weeks from baseline

Outcome Measure Data

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)
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
Measure Participants	0	0

3. Secondary Outcome

Title	Short Form Health Survey (SF-12)
Time Frame	12 weeks from baseline

Outcome Measure Data

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)
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
Measure Participants	0	0

4. Secondary Outcome

Title	Visual Analog Scale for Energy (VAS-E)
Time Frame	12 weeks from baseline

Outcome Measure Data

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)
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
Measure Participants	0	0

5. Secondary Outcome

Title	Visual Analog Scale for Pain (VAS-P)
Time Frame	12 weeks from baseline

Outcome Measure Data

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)
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
Measure Participants	0	0

6. Secondary Outcome

Title	Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame	12 weeks from baseline

Outcome Measure Data

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)
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
Measure Participants	0	0

Adverse Events

Arm/Group Title	Desvenlafaxine + Omega 3 FA Supplement		Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
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%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Desvenlafaxine + Omega 3 FA Supplement		Desvenlafaxine + Placebo (for Omega 3 FA Supplement)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		1/3 (33.3%)
Gastrointestinal disorders
diarrhea	1/2 (50%)	1	0/3 (0%)	0
Nervous system disorders
Memory problems	0/2 (0%)	0	1/3 (33.3%)	1

Limitations/Caveats

Due to very low enrollment in both arms, only descriptive analyses was completed for both arms

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.