NCT02072187

Adjunctive Vitamin D in the Treatment of Non-remitted Depression

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: START Clinic for Mood and Anxiety Disorders · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Depression

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-02-26
• Last updated: 2017-10-02

Locations

1 site across 1 country: Canada