The Effect of Acute Minocycline Administration on Emotional Processing and Cognition in Healthy Volunteers

NCT03768557 | Completed

• 1 other identifier: R50651/RE001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There is growing interest in the possibility of producing more effective antidepressant treatments that target a wider range of pathways involved in depression, including anti-inflammatory and anti-glutamatergic systems. Minocycline is a novel pharmacological agent; in addition to its antibiotic and anti-inflammatory properties, it also acts in the brain as an anti-glutamatergic and anti-oxidant agent. Since both excessive glutamate and oxidative stress are implicated in major depression, and appear to be connected to pro-inflammatory activity, this drug offers a unique tool with which the investigators can measure the effects of targeting these pathways on emotional processing. Participants will receive a single dose of either the drug (200 mg minocycline) or placebo, and will then undergo a well-validated computerised battery of emotional processing tasks that have previously been shown to be sensitive to standard antidepressant drugs. Tasks include presentation of positive and negative emotional words or pictures, to which participants' responses are measured. These tasks have been widely used previously without any adverse effects.

Conditions

Mood; Cognitive Change

Outcome Measures

Primary Outcomes (5)

• Facial Expression Recognition Task

  2 hours

• Emotional Categorization Task

  2 hours

• Emotional Recall Task

  2 hours

• Emotional Recognition Memory Task

  2 hours

• Attentional Dot-Probe

  2 hours

Secondary Outcomes (3)

• N-back Task

  2 hours

• Contextual Cueing Task

  2 hours

• Priming Task

  2 hours

Other Outcomes (5)

• Concentration of the inflammatory marker TNF-alpha in serum Serum inflammatory cytokines and metabolites

  0 and 4 hours

• Concentration of the inflammatory marker IL-6 in serum

  0 and 4 hours

• Concentration of the inflammatory marker C-reactive protein in serum

  0 and 4 hours

Study Arms (2)

Minocycline

EXPERIMENTAL

single dose of minocycline (200mg)

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

lactose pills (400mg)

Other: placebo

Interventions

Minocycline DRUG

Minocycline (200mg)

Minocycline

placebo OTHER

Lactose (400mg)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are willing and able to give informed consent for participation in the study
• Male or female, aged between 18 and 55
• Body mass index (BMI) within the range of 19 - 30 kg/m2
• Sufficiently fluent in English to understand the tasks and instructions
• Female subjects must be outside of their pre-menstrual week on the testing day

You may not qualify if:

• Current or past history of any psychiatric disorder (e.g. depression, anxiety)
• Any medical contra-indication (for example hepatic impairment)
• Current use of any medication which, in the opinion of the study physician, will interfere with minocycline or cause any contraindications
• Known hypersensitivity to tetracyclines or to any of the excipients in minocycline capsules
• Steroidal or non-steroidal anti-inflammatory medication within preceding 2 weeks, including aspirin and ibuprofen
• Congenital or acquired immune deficiency (including participants receiving immunosuppressive or antimitotic drugs)
• Current pregnancy or breastfeeding
• Current substance misuse
• Recent (\< 3 months) use of psychotropic drugs
• Participant in a psychological or medical study involving the use of medication within the last 3 months
• Participant in another study using the same / a similar battery of cognitive / emotional tasks in the last 3 months
• Current smoker of more than 5 cigarettes per day
• Dyslexia (given the nature of the computer tasks)
• Lactose intolerance (placebo is composed of lactose capsules)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Warneford Hospital

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Interventions

Minocycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: December 7, 2018
• Study Start: April 26, 2017
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: April 18, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)