Major Depression, Cancer, Diabetes, Cardiovascular Diseases
Conditions
Keywords
Omega 3 fatty acid, Fish oil, Depression, cancer, diabetes, high blood pressure, cardiovascular
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).
Interventions
DRUGDesvenlafaxine
DIETARY_SUPPLEMENTOmega 3 Fatty acids
DRUGPlacebo (for Omega 3 fatty acid supplement)
Sponsors
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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) | 12 weeks from baseline |
| Visual Analog Scale for Pain (VAS-P) | 12 weeks from baseline |
| Leeds Sleep Evaluation Questionnaire (LSEQ) | 12 weeks from baseline |
Countries
United States
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 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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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) Age range: 53 to 66 years \] Gender: 1 male and 2 females | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
Baseline characteristics
| Characteristic | Desvenlafaxine + Omega 3 FA Supplement | Desvenlafaxine + Placebo (for Omega 3 FA Supplement) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White Non-Hispanic/Latino | 2 participants | 3 participants | 5 participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 1 / 2 | 1 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
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.
Time frame: 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.
Secondary
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: 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.
Secondary
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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.
Secondary
Short Form Health Survey (SF-12)
Time frame: 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.
Secondary
Visual Analog Scale for Energy (VAS-E)
Time frame: 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.
Secondary
Visual Analog Scale for Pain (VAS-P)
Time frame: 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.