- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800161
Trehalose as add-on Therapy in Bipolar Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an investigator-initiated parallel group pilot study. All patients will give a signed informed consent prior to initiation of any study procedure.
Study setting: This unicentric pilot study will be carried out at the Bipolar Disorder Programme of the Hospital Clinic, University of Barcelona. Over 700 Bipolar Disorder patients are currently treated by Bipolar Disorders Program of the Hospital Clinic and University of Barcelona, a tertiary center providing integrated care for patients from a specific catchment area as well as difficult-to-treat bipolar patients derived from all over Spain, as already described elsewhere.
Patients are considered to be enrolled in the study when they sign the informed consent. Patients are considered to be randomized when they are assigned to receive either trehalose or maltose. It is expected that at least 60 patients will be randomly assigned in a 1:1 ratio of trehalose 70g to placebo (maltose 70g). Patients will receive no economic compensation for their participation in the study.
Patients will be evaluated at baseline and at weeks 2, 4 and 6. At baseline, patients will receive explanations regarding the study; after signing the informed consent patients will be interviewed by the study psychiatrist and will be administered the study scales M.I.N.I. International Neuropsychiatric Interview-Plus (MINI-Plus), Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Rating scale for Depression (HAMD), Clinical Global Impression-Bipolar Disorder (CGI-BP), World Health Organization-well being (WHO-wb), Functioning Assessment Short Test (FAST), Cognitive complaints in bipolar disorder rating assessment (COBRA). Furthermore, patients will undergo routine blood analysis including glycaemia, thyroid function (T3, T4, TSH) as well as lithaemia, at baseline and at week 6. At weeks 2 and 4 patients will be administered MADRS, HAMD, CGI-BP, WHO-wb and FAST scales, and eventual side effects will be recorded. At week 6, patients will be interviewed and MADRS, HAMD, CGI-BP, and FAST and will be administered and side effects recorded. At the final visit (week 6), patients will undergo a clinical interview, followed by administration of MADRS, CGI-BP, WHO-wb, COBRA and FAST scales. Full blood analysis will be performed.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Eduard Vieta, MD, PhD
- Phone Number: 3130 +34932275400
- Email: EVIETA@clinic.cat
Study Locations
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Barcelona, Spain, 08036
- Hospital Clinic of Barcelona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Exclusion criteria will be the presence of psychotic features, severe suicidal ideation (score of ≥5 on item 10 of MADRS).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Trehalose
Trehalose 70g/die
|
Trehalose 70g/die
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PLACEBO_COMPARATOR: Placebo
Maltose 70g/die
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Maltose 70g/die
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Outcome: efficacy assessed with the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Mean change from baseline to endpoint (week 8)
|
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)
Time Frame: Mean change from baseline to endpoint (week 8)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcome: response to treatment defined as a reduction of at least 50% on the MADRS (Montgomery-Asberg Depression Rating Scale).
Time Frame: Mean change from baseline to endpoint (week 8)
|
Secondary outcome measures will be response treatment defined as a reduction of at least 50% on the MADRS (Montgomery-Asberg Depression Rating Scale) from baseline to endpoint determination at 8 week.
|
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).
Time Frame: Mean change from baseline to endpoint (week 8)
|
Secondary outcome measures will be response treatment defined as a reduction of at least 50% on the HAMD (Hamilton Rating scale for Depression) from baseline to endpoint determination at 8 week.
|
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).
Time Frame: Mean change from baseline to endpoint (week 8)
|
Secondary outcome measures will be response treatment defined as a reduction of at least 50% on the CGI-BP (Clinical Global Impression-Bipolar Disorder) from baseline to endpoint determination at 8 week.
|
Mean change from baseline to endpoint (week 8)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #14t-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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