Low levels of vitamin D have been associated with depression. This study will test if a vitamin D supplement is helpful in patients with depression who have not found relief with the use of anti-depressant medication. Participants will continue to take their medication plus vitamin D or placebo for 8 weeks. The investigators will monitor their depression symptoms and the investigators think that the people taking vitamin D may have an improvement in their symptoms.
It is hypothesized that deficient or insufficient levels of vitamin D may play a role in the pathogenesis of depression and that supplemental vitamin D may have an antidepressant effect -either through a direct action on the brain or though correction of a deficiency state. The investigators hypothesize that eight weeks of vitamin D supplementation will produce a statistically significant decrease in symptoms of depression compared to placebo for people with non-remitted depression. This study will be a randomized, double-blind placebo-controlled study. Individuals will be recruited who have failed to achieve remission from a depressive episode after a minimum of eight weeks of treatment with a first-line antidepressant, at an adequate dose. They will be randomized to receive either placebo or vitamin D supplementation in addition to their anti-depressant medication, which they will continue to take at the same dose for the duration of the eight week study.There will be an additional follow up visit one month later. The primary objective is to evaluate the efficacy of supplemental vitamin D as an adjunctive treatment in the management of non-remitted depression compared to placebo. Additionally, its safety and tolerability will be assessed. A secondary objective will be to assess the relationship between changes in serum vitamin D levels and mood in order to elucidate information about the role that reversal of vitamin D deficiency may play in the treatment of this condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
START Clinic for Mood and Anxiety Disorders
Toronto, Ontario, Canada
Depression severity
Efficacy of the intervention will be assessed though patients' responses on several self-assessment tools. Mean changes in the scores between the Baseline visit and Week 10 will be observed. Depression will be assessed using the Beck Depression Inventory-II (BDI-II) and the Fawcett-Clark Pleasure Capacity Scale (FCPS). Anxiety will be assessed using the Beck Anxiety Inventory (BAI) and Intolerance of Uncertainty Scale (IUS). Quality of life will be assessed using the Sheehan Disability Scale (SDS).
Time frame: 12 weeks
Safety
At each weekly follow-up visit and the 30-day follow up visit, subjects will be questioned by the clinician on any adverse events related to administration of vitamin D using a non-leading question such as, "Have you felt different in any way since starting the new treatment or since the last visit?" In addition, all adverse experiences observed by the investigator or volunteered spontaneously by the patient will be recorded. A physical examination will be performed at Baseline, visit 10 and the Follow-up visit. Vital signs will be measured at Baseline, visit 6, visit 10 and the Follow-up visit.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.