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Awarded Trial: 14T-012

Grant ID

14T-012

Illness

Bipolar disorder

Primary Drug/Intervention

Trehalose

Primary Dosage

2 g

Secondary Drug Intervention

Saccarose

Secondary Dosage

2g

Other Drug/Intervention

Lithium

Other Dosage

0.5-1.2 mmol/L

Status

Completed

Investigator

Vieta

Sample Size

60

Duration of Study Period for Each Subject

42 days

Outcome Measurements

1) Severity of depressive symptoms as measured by MADRS 2) CGI-BP severity of depression and mania 3) Patient functioning and well-being measured by FAST and the WHO well-being index

Results

Trehalose is a disaccharide which protects cells from hypoxic and anoxic injury, and suppresses protein aggregation. Studies with trehalose on animal models of neurodegenerative diseases show cellular and behavioral beneficial effects. Trehalose enhances autophagy, a process that had been suggested to be involved in the therapeutic action of antidepressant and mood-stabilizing drugs, and may augment the effects of lithium. Dr. Vieta performed a RCT of adjunctive Trehalose added on to lithium in bipolar depression. 17 patients with bipolar depression receiving lithium, were randomized to 6 weeks double-blind with trehalose 2g/d, or placebo. Nine were allocated to trehalose and 8 to placebo, 11 completed the study. The change in the median of the MADRS depression scale from 6 week end-of-study to baseline visit in the trehalose group was -5.1 (SD 5.6) and in the placebo group was -8.3 (SD 5.7), p=NS. This study did not demonstrate Trehalose as an effective add-on treatment for bipolar depression.

Publication

N/A

Link

N/A

PI Name

Eduard Vieta

Degree

MD, PhD

Center

Hospital Clinic de Barcelona

Institution

Centro de Investigacion Biomedica en Red (CIBER)

Address

Villarroel 170

City or Town

Barcelona

State or Province

Catalunya

Zip or Postal Code

08025

Country

Spain

Email Address

evieta@clinic.ub.es