OxSYPan: Oxford Study With Young People on Antidepressants

NCT03436173 | Completed

• 1 other identifier: 12/SC/0030
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fluoxetine is commonly used to treat adolescent depression, but the neural mechanisms underlying antidepressant drugs in the young brain are still poorly understood. This study proposes to investigate the effects of a single dose of fluoxetine on emotional neural processing in a sample of depressed adolescents, using functional Magnetic Resonance Imaging (fMRI).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Neural activity (BOLD response) in response to angry faces

  fMRI data collected during a faces task involving angry, happy and fearful faces

  6 hours post-intervention

Secondary Outcomes (2)

• Neural activity (BOLD response) in task measuring emotional regulation

  6 hours post-intervention

• Resting-state functional connectivity

  6 hours post-intervention

Study Arms (2)

Fluoxetine

EXPERIMENTAL

Fluoxetine 10 mg/2.5 ml

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

Peppermint syrup measured to equivalent volume

Other: Peppermint syrup

Interventions

Fluoxetine DRUG

Fluoxetine 10 mg/2.5 ml mixed with water

Also known as: Prozac

Fluoxetine

Peppermint syrup OTHER

Liquid peppermint syrup measured to the equivalent volume and mixed with water

Placebo

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Current episode of depression with or without comorbid anxiety and in need of antidepressant medication (as assessed by the Adolescent Psychiatrist);
• Participant and parent/legal guardian (for participants younger than 16) are willing and able to give informed consent for participation in the study;
• Male or female, aged 13-18;
• Sufficiently fluent in English to understand the task and instructions.

You may not qualify if:

• Current or past psychosis or mania;
• Current substance misuse;
• Psychotropic medication usage within the past 6 weeks;
• Contraindication to fMRI (e.g. metal in body, claustrophobia, pregnancy, etc);
• Risk of waiting 5-7 days before the initiation of medication assessed as posing serious risk (as assessed by the Adolescent Psychiatrist).

Sponsors & Collaborators

• University of Oxford: lead

Related Publications (3)

• Capitao LP, Murphy SE, Browning M, Cowen PJ, Harmer CJ. Acute fluoxetine modulates emotional processing in young adult volunteers. Psychol Med. 2015 Aug;45(11):2295-308. doi: 10.1017/S0033291715000240. Epub 2015 Apr 13.

  PMID: 25864939 BACKGROUND

• American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders, 5th edn: DSM-5. American Psychiatric Association: Arlington, VA.

  BACKGROUND

• Capitao LP, Chapman R, Filippini N, Wright L, Murphy SE, James A, Cowen PJ, Harmer CJ. Acute neural effects of fluoxetine on emotional regulation in depressed adolescents. Psychol Med. 2023 Jul;53(10):4799-4810. doi: 10.1017/S0033291722001805. Epub 2022 Jul 29.

  PMID: 35903009 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 19, 2018
• Study Start: May 23, 2012
• Primary Completion: November 10, 2015
• Study Completion: November 10, 2015
• Last Updated: February 20, 2018

Record last verified: 2018-02