Effectiveness of Probiotics as an additional treatment in Major depressive Disorder in community: Pilot Study

Not Applicable

• Conditions: Major Depressive Disorder; Mental Health - Depression

• Registration Number: ACTRN12621000115831
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-04
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Adults aged between 18 and 65 years

- Living in the community

-English speaking

-Able to give informed consent

-Currently experiencing an episode of MDD of mild to moderate* severity based on the Diagnostic and statistical manual of mental disorders (5th ed.)

- Attending an existing health care provider

* Mild: Few,If any, symptoms in excess of those required to make the diagnosis are present,the intensity of the symptoms is distressing but manageable,an the symptoms result in minor impairment in social or occupational functioning.

Moderate: The number of symptoms,intensity of symptoms,and/or functional impairment are between those specified for ‘mild’ and severe”.

Severe: The number of symptoms is substantially in excess of that required to make the diagnosis,the intensity of the symptoms is seriously distressing and unmanageable,and the symptoms markedly interfere with social and occupational functioning.

Exclusion Criteria

- Illnesses that contribute to immunosuppression or inflammatory conditions

-People who take immunosuppressants

-Currently suffering from an infection and have been taking antibiotics

-On regular medications other than antidepressants especially those which affect the gut microbiota (e.g., Omeprazole, over the counter probiotics) or anti-inflammatory medications like NSAID’s.

-Acutely suicidal or at high risk of harming others or properties

-Currently diagnosed with Schizophrenia, Schizoaffective disorder or eating disorder

- Have been diagnosed with Bipolar Affective disorder in the past

- Any form of substance abuse or dependence in the last two years.

-Significant comorbid physical illnesses, e.g., autoimmune disorders, inflammatory bowel conditions, traumatic brain injury, neurological disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of symptoms of Major Depressive Disorder as measured using a scale called Montgomery-Asberg Depression Rating Scale (MADRS)[eight weeks after ingesting Probiotics/ Maltodextrin powder along with their usual treatment ]