Comparison of Vitamin B12 Supplementation to Selective Serotonin Reuptake Inhibitor (SSRI) Versus SSRI Antidepressant Treatment Alone

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

Baseline and 3 month measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and response rates compared.

It had two arms (groups): Vitamin B12 with antidepressants (active comparator) and Placebo injections dextrose water (placebo comparator).

Subjects in this arm will receive vitamin B12 supplement (injectable)along with their routine antidepressant treatment as prescribed by their primary physicians. subjects will be blind to their arm allocation and will receive injections in a concealed manner with injection vials covered with foil.

Subjects in this arm will receive placebo injections which will contain only dextrose water. They will also receive 6 injections on a weekly basis and the injection vials will be covered with foil to ensure masking.

The registry classes the interventions as dietary supplement.

More on the Plan

Vitamin B12 plays an important role in DNA synthesis and neurological function.

Recent literature has seen links between this vitamin and depression.

Hyperhomocysteinemia may have direct effects on neurotransmitters implicated in depression.

Folate deficiency has also been linked with delay in treatment response as well as relapse.

Who Took Part

268 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with low normal B12 levels in serum (\>191 but \< 300 pg/ml). Those who will provide informed consent.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: patients with concurrent unstable medical illness; history of manic episodes or psychotic illness; psychotic symptoms within depressive episode.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-04 with completion listed for 2010-06.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 268 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.