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Sumor as Adjuvant Therapy in Treatment-resistant Major Depression (SUSCA)

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
SUMOR
Placebo
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder according to DSM-5 criteria
  • Treatment-resistant status, assessed by clinical interview, after four weeks after SSRI therapy prescription as per NICE guidelines (National Institute for Health and Care Excellence, 2009)
  • Age between 18 and 65 years
  • Signature of informed consent

Exclusion Criteria:

  • Presence of intellectual disability or illiteracy
  • Diagnosis of a disorder belonging to the spectrum of schizophrenia or other psychotic disorders according to DSM-5
  • Diagnosis of a disorder belonging to the bipolar spectrum according to DSM-5
  • Concomitant intake of therapy with other antidepressants, antipsychotics or mood stabilizers at the time of evaluation or in the previous 4 weeks
  • State of pregnancy

Sites / Locations

  • Azienda Ospedaliero Universitaria CareggiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

SUMOR

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D)
The change in total HAM-D score between baseline and the 8-week follow-up was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on scales ranging from 0-2 to 0-4, and the sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes. Scores over 24 are considered indicative of severe depressive symptoms.

Secondary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D)
The change in total HAM-D score between baseline and the intermediate 2-week and 4-week follow-ups were considered secondary outcomes measures.
Hamilton Anxiety Scale (HAM-A)
The change in total HAM-A score between baseline and the 2-week, 4-week and 8-week follow-ups were considered secondary outcomes measures. This measure is a clinician rated inventory of anxiety symptoms. The sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes.
SIDE
A self-assessment questionnaire for undesirable effects in psychopharmacological treatment, developed by the Department of Psychiatry of Vanderbilt University in Nashville. It allows to investigate the presence or absence of 48 symptoms, exploring their severity and the relationship with the treatment.
Depressive symptoms remission
Remission rate of Major Depression in the two groups over the course of treatment, defining remission as a score ≤ 7 on the HAM-D scale

Full Information

First Posted
April 2, 2021
Last Updated
October 14, 2021
Sponsor
Azienda Ospedaliero-Universitaria Careggi
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1. Study Identification

Unique Protocol Identification Number
NCT04832178
Brief Title
Sumor as Adjuvant Therapy in Treatment-resistant Major Depression
Acronym
SUSCA
Official Title
Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sumor is a food supplement that combines the main coenzymes of the S-Adenosyl methionine (SAMe) cycle, namely vitamins B6, B12 and folate, with SAMe and betaine. Sumor also contains vitamin C, a molecule that has shown promise in the treatment of depression in experimental models, and selenium, an antioxidant agent whose blood deficiency has been associated with depressive symptoms in some preliminary studies. There are no studies in the literature on the efficacy of this combination in the adjuvant therapy of depression. The purpose of this study is to compare the effects of Sumor in co-therapy with an SSRI antidepressant versus co-therapy with placebo in patients with treatment-resistant Major Depressive Disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
SUMOR
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
SUMOR
Intervention Description
SUMOR is a food supplement distributed in Italy by ArcaPharma. regularly entered in the register of Food Supplements of the Ministry of Health (number 62590). Formulated in prolonged-release tablets, each tablet contains the following substances: S-Adenosyl-L-Methionine sulfate p-toluenesulfonate 250 mg Betaine hydrochloride 250 mg Vitamin C 80 mg Vitamin B1 1.1 mg Vitamin B2 1.4 mg Vitamin B6 1.4 mg Vitamin B12 2,5 µg Folic Acid 200 µg Selenium 37 µg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet will be identical in appearance to the experimental product (SUMOR).
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
The change in total HAM-D score between baseline and the 8-week follow-up was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on scales ranging from 0-2 to 0-4, and the sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes. Scores over 24 are considered indicative of severe depressive symptoms.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
The change in total HAM-D score between baseline and the intermediate 2-week and 4-week follow-ups were considered secondary outcomes measures.
Time Frame
Baseline, 2 weeks, and 4 weeks
Title
Hamilton Anxiety Scale (HAM-A)
Description
The change in total HAM-A score between baseline and the 2-week, 4-week and 8-week follow-ups were considered secondary outcomes measures. This measure is a clinician rated inventory of anxiety symptoms. The sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes.
Time Frame
Baseline, 2 weeks, 4 weeks and 8 weeks
Title
SIDE
Description
A self-assessment questionnaire for undesirable effects in psychopharmacological treatment, developed by the Department of Psychiatry of Vanderbilt University in Nashville. It allows to investigate the presence or absence of 48 symptoms, exploring their severity and the relationship with the treatment.
Time Frame
Baseline, 2 weeks, 4 weeks and 8 weeks
Title
Depressive symptoms remission
Description
Remission rate of Major Depression in the two groups over the course of treatment, defining remission as a score ≤ 7 on the HAM-D scale
Time Frame
Baseline, 2 weeks, 4 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Major Depressive Disorder according to DSM-5 criteria Treatment-resistant status, assessed by clinical interview, after four weeks after SSRI therapy prescription as per NICE guidelines (National Institute for Health and Care Excellence, 2009) Age between 18 and 65 years Signature of informed consent Exclusion Criteria: Presence of intellectual disability or illiteracy Diagnosis of a disorder belonging to the spectrum of schizophrenia or other psychotic disorders according to DSM-5 Diagnosis of a disorder belonging to the bipolar spectrum according to DSM-5 Concomitant intake of therapy with other antidepressants, antipsychotics or mood stabilizers at the time of evaluation or in the previous 4 weeks State of pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valdo Ricca, MD
Phone
+390557947478
Email
valdo.ricca@unifi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Rotella, PhD, MD
Organizational Affiliation
Azienda Ospedaliero-Universitaria Careggi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Florence
ZIP/Postal Code
50100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Rotella, PhD, MD
Phone
+390557947478
Email
francesco.rotella@unifi.it
First Name & Middle Initial & Last Name & Degree
Francesco Rotella, PhD, MD
First Name & Middle Initial & Last Name & Degree
Emanuele Cassioli, MD
First Name & Middle Initial & Last Name & Degree
Daniele Busatta, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

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