Not provided
Not provided
Not provided
Not provided
Not provided
Lack of recruitment and no resources
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desvenlafaxine + Omega 3 FA supplement | Experimental | Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period |
|
| Desvenlafaxine + Placebo (for Omega 3 FA supplement) | Active Comparator | Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale | Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions. | 12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 12 weeks from baseline | |
| Short Form Health Survey (SF-12) | 12 weeks from baseline | |
| Visual Analog Scale for Energy (VAS-E) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jayesh Kamath, MD PhD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
One subject who was consented did not meet the threshold for depression symptomatology during screening as determined by the Hospital Anxiety and Depression Scale.
A total of 30 subjects underwent phone screening. Of these, a total of 6 subjects were consented and 5 met study eligibility criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 Age range: 53 to 66 years Gender: 1 male and 1 female |
| BG001 | Desvenlafaxine + Placebo (for Omega 3 FA Supplement) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Anxiety and Depression Scale | Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions. | 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. | Posted | 12 weeks from baseline |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Stomach upsets |
Due to very low enrollment in both arms, only descriptive analyses was completed for both arms
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jayesh Kamath MD PhD | UConn Health Center | 8606796727 | jkamath@uchc.edu |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D009369 | Neoplasms |
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D003863 | Depression |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Omega 3 Fatty acids | Dietary Supplement |
|
| Placebo (for Omega 3 fatty acid supplement) | Drug |
|
| 12 weeks from baseline |
| Visual Analog Scale for Pain (VAS-P) | 12 weeks from baseline |
| Leeds Sleep Evaluation Questionnaire (LSEQ) | 12 weeks from baseline |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period
Desvenlafaxine
Placebo (for Omega 3 fatty acid supplement)
|
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) | 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. | Posted | 12 weeks from baseline |
|
|
| Secondary | Short Form Health Survey (SF-12) | 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. | Posted | 12 weeks from baseline |
|
|
| Secondary | Visual Analog Scale for Energy (VAS-E) | 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. | Posted | 12 weeks from baseline |
|
|
| Secondary | Visual Analog Scale for Pain (VAS-P) | 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. | Posted | 12 weeks from baseline |
|
|
| Secondary | Leeds Sleep Evaluation Questionnaire (LSEQ) | 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. | Posted | 12 weeks from baseline |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | 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 | 0 | 3 | 0 | 3 | 1 | 3 |
| Memory problems | Nervous system disorders | Non-systematic Assessment | Memory problems |
|
Not provided
Not provided
Not provided
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |