Trehalose as add-on Therapy in Bipolar Depression

NCT02800161 | Completed Phase 3

• 1 other identifier: #14t-012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The ongoing research on bipolar disorder (BD) has highlighted its pervasive and debilitating nature, characterized by lifelong recurrent episodes and residual intraepisodic symptomatology. Epidemiologic, comorbidity, cost-of illness, and mortality studies have reported dramatic illness-associated morbidity and premature mortality in bipolar patients. The efficacy and safety of antidepressant drug treatment in BD is the subject of long-standing debate based on a scientific literature that is limited and inconsistent. The evidence base for the use of antidepressant drugs in BD is strikingly weak, and there is insufficient evidence for treatment benefits with antidepressants combined with mood stabilizers. The need to develop new agents for the treatment of depression, and in particular bipolar depression, with better efficacy and/or tolerability, remains unmet. In the past years there has been increasing interest in the health benefits of supplemental and/or dietary substances in the treatment and prevention of depression. The disaccharide trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation. In vivo studies with trehalose show cellular and behavioural beneficial effects in animal models of neurodegenerative diseases. Moreover, trehalose was shown to enhance autophagy, a process that had been recently suggested to be involved in the therapeutic action of antidepressant and mood-stabilizing drugs. In fact, trehalose may have antidepressant-like properties and that the trehalose induced behavioral changes are possibly related to trehalose effects to enhance autophagy. Furthermore, preliminary data indicates that trehalose also augments lithium effects in animal models (mice). Based on this hypothesis, this project aims to conduct a study to assess the efficacy and tolerability of trehalose as adjunctive treatment to lithium in bipolar depression.

Conditions

Bipolar Disorder; Bipolar Depression

Outcome Measures

Primary Outcomes (2)

• Primary Outcome: efficacy assessed with the Montgomery-Asberg Depression Rating Scale (MADRS)

  The primary outcome measure is evaluation of efficacy in terms of the mean change from baseline in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) after the 8 weeks of the study.

  Mean change from baseline to endpoint (week 8)

• Primary Outcome: efficacy assessed with the Hamilton Rating scale for Depression (HAMD)

  The primary outcome measure is evaluation of efficacy in terms of the mean change from baseline in the total score of the Hamilton Rating scale for Depression (HAMD) after the 8 weeks of the study.

  Mean change from baseline to endpoint (week 8)

Secondary Outcomes (3)

• Secondary Outcome: response to treatment defined as a reduction of at least 50% on the MADRS (Montgomery-Asberg Depression Rating Scale).

  Mean change from baseline to endpoint (week 8)

• Secondary Outcome: response to treatment defined as a reduction of at least 50% on the HAMD (Hamilton Rating scale for Depression).

  Mean change from baseline to endpoint (week 8)

• Secondary Outcome: response to treatment defined as a reduction of at least 50% on the CGI-BP (Clinical Global Impression-Bipolar Disorder).

  Mean change from baseline to endpoint (week 8)

Study Arms (2)

Trehalose

ACTIVE COMPARATOR

Trehalose 70g/die

Drug: Trehalose

Placebo

PLACEBO COMPARATOR

Maltose 70g/die

Drug: Maltose

Interventions

Trehalose DRUG

Trehalose 70g/die

Trehalose

Maltose DRUG

Maltose 70g/die

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:

• Bipolar I and II patients aged between 18 and 65.
• Bipolar disorder type I or II and a current major depressive episode (Montgomery-Asberg Depression Rating Scale (MADRS) ≥18.
• Clinical Global Impression-Bipolar version (CGI-BP)≥4.
• All patients need to be receiving lithium at a steady dose (0.5-1.2 mmol/L) during at least 2 weeks prior to the study.
• Other mood stabilizers added to lithium are permitted but at steady dose during at least 2 weeks prior to the study.
• Other psychopharmacological treatments should be at stable dose 2 weeks prior to the study.

You may not qualify if:

• A severe personality disorder suggesting noncompliance.
• Diabetes Mellitus, any severe neurologic or other somatic illness and the use of somatic medication that could influence the mood.

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Trehalose; Maltose

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Officials

• Eduard Vieta, MD,PhD

  Principal Investigator CIBER

  PRINCIPAL INVESTIGATOR

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 GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)