The Effect of SSRIs on Threat of Shock Potentiated Neural Circuitry

U

UCLH/UCL Joint Research Office

Status

Completed

Conditions

Anxiety

Treatments

Drug: Placebo

Drug: Escitalopram

Study type

Interventional

Funder types

Other

Identifiers

NCT07074652

6198/002

Details and patient eligibility

About

This study aims to increase the knowledge about psychological processes which may contribute to mental health problems such as depression and anxiety. This study aims to investigate if administering Escitalopram, an antidepressant which increases serotonin levels in parts of the brain, affects how the brain processes emotional information. It is hoped that measuring these changes will increase the understanding of processes involved in mental health problems.

Enrollment

145 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

Healthy Controls:

Fluency in English
Registration with a UK General Practitioner
Capacity for consent
No personal history of long-term medical conditions or psychiatric illness (including substance dependence, assessed with the Mini International Neuropsychiatric Interview)

Anxious Individuals:

Fluency in English
Registration with a UK General Practitioner
Capacity for consent
Meeting criteria for generalised anxiety disorder, panic disorder and/or agoraphobia (also assessed with the Mini International Neuropsychiatric Interview); permitted comorbid conditions were: major depressive disorder, obsessive-compulsive disorder and/or post-traumatic stress disorder

EXCLUSION CRITERIA

Healthy Controls and Anxious Individuals:

Having consumed alcohol within 12 hours prior to the study
having used illicit drugs within 3 months prior to the study
Having had any contraindications to MRI scanning
Being pregnant or breastfeeding
Having had impaired or uncorrected vision or hearing

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

145 participants in 4 patient groups, including a placebo group

Healthy Control - Escitalopram

Active Comparator group

Description:

Participants took 10mg escitalopram for 2-3 weeks, once daily. Escitalopram was administered in the form of a tablet, manufactured and donated for research by Lundbeck (tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate; tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000). Exact length of administration was dependent on participants' availability to attend their second scan.

Treatment:

Drug: Escitalopram

Healthy Control - Placebo

Placebo Comparator group

Description:

Participants took a placebo tablet for 2-3 weeks, once daily. Placebo was administered in the form of a tablet, manufactured and donated for research by Lundbeck and matching the escitalopram tablet given to the other study groups in colour and size. Exact length of administration was dependent on participants' availability to attend their second scan.

Treatment:

Drug: Placebo

Anxious Individuals - Escitalopram

Experimental group

Description:

Participants took 10mg escitalopram for 2-3 weeks, once daily. Escitalopram was administered in the form of a tablet, manufactured and donated for research by Lundbeck (tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate; tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000). Exact length of administration was dependent on participants' availability to attend their second scan.

Treatment:

Drug: Escitalopram

Anxious Individuals - Placebo

Placebo Comparator group

Description:

Participants took a placebo tablet for 2-3 weeks, once daily. Placebo was administered in the form of a tablet, manufactured and donated for research by Lundbeck and matching the escitalopram tablet given to the other study groups in colour and size. Exact length of administration was dependent on participants' availability to attend their second scan.

Treatment:

Drug: Placebo

Trial contacts and locations

1

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