Adjunctive Vitamin D in the Treatment of Non-remitted Depression

NCT02072187 | Terminated Phase 3 DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Depression; Vitamin D; Complementary and Alternative Medicine; Supplements; Non Remitted Depression

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (1)

• Safety

  12 weeks

Study Arms (2)

Active

EXPERIMENTAL

The vitamin D formula that will be used is Bio-D Mulsion 1000, produced by Biotics Research Corporation. This formula contains: Vitamin D (cholecalciferol), water and acacia gum and sesame oil. Participants will be provided with a dose of vitamin D at each visit beginning at the Baseline visit. The weekly dose of vitamin D will be 28 000IU (the equivalent of 4000IU daily) for a period of eight weeks. If baseline or week 4 serum vitamin D levels are measured as \>100nmol/L, the dose will be reduced to 14 000IU (the equivalent of 2000IU daily). The dose will be dispensed, using the bottle dropper, onto a disposable plastic spoon which the participant will insert into their mouth.

Dietary Supplement: Active

Placebo

PLACEBO COMPARATOR

The placebo formula, also produced by Biotics Research Corporation, will contain all of the non-medicinal ingredients but no vitamin D. It will be identical in appearance and taste. Participants will be provided with a dose of the placebo at each visit beginning at the Baseline visit. The weekly dose will be 28 drops or 14 drops if serum Vitamin D levels are \>100nmol/L. The dose will be dispensed, using the bottle dropper, onto a disposable plastic spoon which the participant will insert into their mouth.

Dietary Supplement: Placebo

Interventions

Active DIETARY_SUPPLEMENT

Also known as: Bio-D Mulsion 1000

Active

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the following criteria are eligible for enrolment in this trial:
• Men or Women aged 18 to 65 (extremes included) who are out-patients
• Patients with a primary diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV-TR criteria (16), confirmed using the Mini International Neuropsychiatric Interview (MINI)
• Patients who have failed to respond to treatment with a single pharmacological antidepressant agent at an adequate dose as defined by a lack of remission from the current depressive episode (score of 7 or less on the Hamilton Depression Scale) after eight weeks of treatment
• On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigators opinion, in a suitable condition
• Willing and able to attend study appointments in the correct time windows

You may not qualify if:

• Any other Axis I disorder that was a primary disorder in the past 6 months. Co-morbid anxiety disorders will be permitted as long as MDD is judged to be the primary diagnosis.
• Current or past mania or hypomania or a mixed mood disorder phase suggestive of a bipolar mood disorder as defined by the DSM-IV-TR (16)
• Current or past psychotic disorder
• Diagnosis of a mental retardation, dementia or other cognitive disorder
• Current or past alcohol or drug use as defined in the DSM-IV-TR (16) in the last six months
• Commencement of formal psychotherapy 30 days prior to Screening (formal psychotherapy for study purposes includes Cognitive Behavioural Therapy (CBT) or acute CBT treatment in individual therapy)
• Current use of psychiatric medication other than the antidepressant to which the patient failed to show sufficient response. Short half-life hypnotics (anxiolytics) will be allowed p.r.n. in the evening for the treatment of insomnia
• Patient using herbal or nutritional treatments judged to have anti-depressant effects unless they have discontinued its use with their physician's consent more than 2 weeks prior to entry into the study
• Clinical interpretation of apparent suicide risk
• Supplementation of vitamin D \>200IU per day in the past 6 months
• Baseline serum vitamin D of \>150nmol/L
• A history of parathyroid disease or kidney stones
• Pregnant or breast-feeding females
• Serious medical illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance, diabetes, dyslipidemia and hypertension;or in the judgment of investigator as not being appropriate for the study on medical grounds
• The patient is, in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol, or is unsuitable for any other reasons.

Sponsors & Collaborators

• START Clinic for Mood and Anxiety Disorders: lead
• The Canadian College of Naturopathic Medicine: collaborator

Study Sites (1)

START Clinic for Mood and Anxiety Disorders

Toronto, Ontario, M4W 2N4, Canada

Location

Related Publications (1)

• Unable to connect to PubMed to validate , last attempt on July 26, 2013 at 10:28 AM EDT

  BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Director MD, FRCPC

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

CA (1)