None listed
Conditions
Brief summary
The primary aim of this study is to investigate the efficacy and safety of SAMe versus a combination nutraceutical (SAMe + 5-HTP, EPA and zinc) as adjunctive treatments in adults (n=300) with major depressive disorder in an 8-week, double-blind, randomised, placebo-controlled trial. The primary outcome measure is severity of depressive symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS).
Interventions
An 8-week, double-blind, randomised, placebo-controlled trial (n=300) of adjunctive SAMe versus a combination nutraceutical in the treatment of major depressive disorder (MDD).
Participants take 2 tablets and 2 capsules orally each day for 8 weeks.
Group A: SAMe (800mg/day) + cofactors folinic acid (500mcg/day) and vitamin B12 (200mcg/day);
Group B: enhanced SAMe combination nutraceutical formulation consisting of SAMe (800mg/day), Omega-3 concentrate (EPA-esters 1000mg/day, DHA-esters 656
An 8-week, double-blind, randomised, placebo-controlled trial (n=300) of adjunctive SAMe versus a combination nutraceutical in the treatment of major depressive disorder (MDD). Participants take 2 tablets and 2 capsules orally each day for 8 weeks. Group A: SAMe (800mg/day) + cofactors folinic acid (500mcg/day) and vitamin B12 (200mcg/day); Group B: enhanced SAMe combination nutraceutical formulation consisting of SAMe (800mg/day), Omega-3 concentrate (EPA-esters 1000mg/day, DHA-esters 656mg/day), 5-HTP (200mg/day), zinc picolinate (30 mg/day) + cofactors folinic acid (500mcg/day), vitamin B12 (200mcg per day), vitamin B6 (200mg/day), vitamin E (40IU/day), vitamin C (60mg per day), and magnesium amino acid chelate (40mg per day). Treatment adherence will be monitored through tablet and capsule counts at fortnightly assessment sessions.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Aged 18 to 75; fluent in written and spoken English; has the capacity to consent to the study and follow its procedures; fulfills the DSM-IV-TR and DSM-5 diagnostic criteria for Major Depressive Disorder on structured interview (MINI-Plus); presents with depression (MADRS = or > 18) at time of study entry; meets SAFER 2.0 criteria for a stable episode of depression; currently taking one of the following antidepressants for a minimum of four weeks, and on a stable dose for a minimum of two weeks: agomelatine (= or > 25 mg/day), citalopram (= or > 20 mg/day), desvenlafaxine (= or > 25mg/day), duloxetine (= or > 60 mg/day), escitalopram (= or > 10 mg/day), fluoxetine (= or > 20 mg/day), fluvoxamine (= or > 50 mg/day), mirtazapine (= or > 30 mg/day), paroxetine (= or > 20 mg/day), reboxetine (= or > 8 mg/day), sertraline (= or > 50 mg/day), venlafaxine (= or > 150 mg/day)
Exclusion criteria
Currently taking MAOIs or tricylic antidepressants; current use of any nutraceutical including a multi-vitamin, omega-3, or psychotropic herbal medicine e.g. St John’s wort (a two week washout can occur before inclusion); presents with suicidal ideation (> 3 on MADRS suicidal thoughts domain) at time of study entry; three or more failed trials of pharmacotherapy or somatic therapy (e.g. ECT, TMS) for the current major depressive episode; recently commenced psychotherapy (> 4 weeks of stable treatment acceptable); taking warfarin or phenytoin; diagnosis of bipolar disorder or schizophrenia on structured interview (MINI-Plus); a primary clinical diagnosis of a substance/alcohol use disorder within the last 12 months on structured interview (MINI-Plus); known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or serious cardio/cerebrovascular disease); pregnancy or breastfeeding; not using medically approved contraception (including abstinence) if female and of childbearing age; allergy to seafood.
Outcome results
None listed