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PF-04995274 and Emotional Processing in Treatment Resistant Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PF-04995274 and Emotional Processing in Treatment Resistant Depression

The Effects of PF-04995274 on Emotional Processing in Treatment-resistant, Medicated, Depressed Patients

NCT03515733•University of Oxford

Summary

This study will test whether seven days adjunctive administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and non-emotional cognition in medicated, treatment-resistant depressed patients compared to placebo.

Detailed Description

This study uses a double-blind, placebo-controlled, randomised between-groups design to test if adjunctive administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in medicated treatment-resistant depressed patients. Participants are patients who fulfill criteria for current episode of Major Depressive Disorder (MDD) and have shown lack of response to antidepressant treatment, and they will be randomised to receive 7 days treatment with either PF-04995274 (15 mg daily) or a matched placebo. Participants will come for a Screening Visit, a First Dose Visit, and a Research Visit (including measures of emotional processing and non-emotion cognition).

Eligibility

Age

16 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female;
•Aged 18-65 years;
•Willing and able to give informed consent for participation in the study;
•Sufficiently fluent English to understand and complete the tasks;
•Registered with a GP and consents to GP being informed of participation in study;
•Participants need to meet a number of concurrent clinical criteria:
•Current criteria for Major Depressive Disorder \[as determined by the Structured Clinical interview for DSM-V (SCID)\];
•Failure within the current depressive episode to respond clinically to at least one course of antidepressant therapy, each given at a therapeutic dose for at least four weeks \[as determined by use of the MGH Antidepressant Treatment Response Questionnaire (ATRQ)\];
•Currently taking an antidepressant, which must be either a Selective Serotonin Reuptake Inhibitor (SSRI) - with the exception of fluoxetine, paroxetine or fluvoxamine - or a Serotonin-norepinephrine reuptake inhibitor (SNRI) ; Participants currently taking excluded medications can be switched to sertraline or citalopram;
•Participants engaging in sex with a risk of pregnancy must agree to use a highly effective method of contraception from Screening Visit until 30 days after receiving study medication treatment, and male participants must not donate sperm.

Exclusion Criteria

•History of or current DSM-V bipolar disorder, schizophrenia or eating disorders. Participants who fulfil current criteria for other comorbid disorders may still be entered into the study, if, in the opinion of the Investigator, the psychiatric diagnosis will not compromise safety or affect data quality;
•First-degree relative with a diagnosis of Bipolar Disorder type 1;
•Participants currently taking strong cytochrome P450 (CYPs) enzymes inhibitors, such as fluoxetine, paroxetine or fluvoxamine (in order to avoid drug-drug interactions);
•Participants currently taking psychotropic medications which in the opinion of the investigator may interfere with the safety of the participant or the scientific integrity of the study;
•Participants who have previously failed a combination/augmentation therapy (i.e., therapy with the combination of two or more pharmacological agents) for the treatment of depression, which in the opinion of the Investigator may reduce the likelihood of responding;
•Electroconvulsive therapy for the treatment of the current episode of depression;
•Participants undergoing any form of face-to-face structured psychological treatment during the study;
•Clinically significant abnormal values for liver function tests, clinical chemistry, urine drug screen, blood pressure measurement and ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures;
•History of stimulant abuse (lifetime; e.g. amphetamine, cocaine), or of alcohol abuse within one year or of alcohol dependence within the lifetime;
•History of, or current medical conditions which in the opinion of the investigator may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, severe hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumors, severe neurological problems (like Parkinson's Disease; blackouts requiring hospitalisation);
+14 more criteria

Locations (1)

University of Oxford

Oxford, Oxfordshire, United Kingdom

Key Dates

Start Date

May 31, 2018

Primary Completion Date

July 26, 2022

Completion Date

July 26, 2022

Last Updated

November 4, 2022

Enrollment

ACTUAL participants

Conditions

Depression, UnipolarTreatment Resistant Depression

Interventions

PF-04995274

DRUG

Placebo Oral Tablet

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

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Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PF-04995274 and Emotional Processing in Treatment Resistant Depression

Inclusion Criteria

Exclusion Criteria

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