Clinical trial · Interventional
Omega 3 FA Supplements as Augmentation in the Treatment of Depression
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.
NCT01803711CI-TRIAL-00030920terminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of recruitment and no resources
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Diabetes | — | UNRESOLVED | — |
| Major Depression | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Desvenlafaxine | Drug | — | UNRESOLVED |
| Omega 3 Fatty acids | Dietary Supplement | — | UNRESOLVED |
| Placebo (for Omega 3 fatty acid supplement) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Desvenlafaxine + Omega 3 FA supplement
- description
- Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
- interventionNames
- Drug: Desvenlafaxine
- Dietary Supplement: Omega 3 Fatty acids
- type
- ACTIVE_COMPARATOR
- label
- Desvenlafaxine + Placebo (for Omega 3 FA supplement)
- description
- Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period
- interventionNames
- Drug: Desvenlafaxine
- Drug: Placebo (for Omega 3 fatty acid supplement)
Primary outcomes (1)
- measure
- Hospital Anxiety and Depression Scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.