PF-04995274 and Emotional Processing in Un-medicated Depression

NCT03516604

Last updated date
Study Location
University of Oxford
Oxford, Oxfordshire, OX3 7JX, United Kingdom
Contact
01865 618324

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Unipolar Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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;

- Meet DSM-V criteria for current Major Depressive Disorder [as determined by the Structured Clinical interview for DSM-V (SCID)];

- Participant must have received no drug or face-to-face psychological treatment for the current episode of depression/ in the previous six weeks;

- 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, female participants must not breastfeed, and male participants must not donate sperm.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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;


- Current usage of psychotropic medication;


- Failure to respond to antidepressant medication in current episode;


- 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; blackouts requiring hospitalisation);


- Medical conditions that may alter the hemodynamic parameters underlying the BOLD
signal (e.g., inadequately treated hypertension, diabetes mellitus);


- Clinically significant risk of suicide;


- Current pregnancy (as determined by urine pregnancy test taken during Screening and
First Dose Visits), breastfeeding or planning a pregnancy during the course of the
study;


- Participant not willing to use a suitable method of contraception for 30 days after
receiving study drug treatment;


- Any contraindication to MRI scanning (e.g. metal objects in body, pacemakers,
significant claustrophobia, pregnancy);


- Participants with Body Mass Index (BMI) outside the 18 to 36 kg/m2 range at the
Screening Visit.


- Night-shift working or recent travel involving significant change of timezones;


- Excessive caffeine consumption, i.e., consumption higher than 8 cups of standard
caffeinated drinks (tea, instant coffee) or higher than 6 cups of stronger coffee or
other drinks containing methylxanthines such as coca cola or Red Bull per day;


- Participation in a psychological or medical study involving the use of medication
within the last 3 months;


- Previous participation in a study using the same, or similar, emotional processing
tasks;


- Smoker > 10 cigarettes per day or similar levels of tobacco consumption in other
forms.


- Participant received prescribed medication within 28 days prior to Visit 2 (apart from
the contraceptive pill). Participants who have taken prescription medication may still
be entered into the study, if, in the opinion of the Investigator, the medication
received will not interfere with the study procedures or compromise safety;


- Participant received non-prescription medication, including supplements such as
vitamins and herbal supplements within 48 hours prior to Visit 2 (apart from
paracetamol). Participants who have taken non-prescription medication may still be
entered into the study, if, in the opinion of the Investigator, the medication
received will not interfere with the study procedures or compromise safety;


- Participant with a known hypersensitivity to PF-04995274, citalopram or any other
serotonergic agents;


- Participant with planned medical treatment within the study period that might
interfere with the study procedures;


- Participant who is unlikely to comply with the clinical study protocol or is
unsuitable for any other reason, in the opinion of the Investigator.

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Advanced Information
Descriptive Information
Brief Title  ICMJE PF-04995274 and Emotional Processing in Un-medicated Depression
Official Title  ICMJE The Effects of PF-04995274 on Emotional Processing in Un-medicated Depressed Patients
Brief Summary This study will test whether seven days administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in unmedicated depressed patients compared to placebo. The study will also include a group of patients randomised to seven days administration of citalopram (20 mg), which is a standard treatment for depression.
Detailed Description This study uses a double-blind, placebo-controlled, randomised between-groups design to test if administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in unmedicated depressed patients. Participants are patients who fulfill criteria for current episode of Major Depressive Disorder (MDD), and they will be randomised to receive 7 days treatment with either PF-04995274 (15 mg daily), citalopram (20 mg daily) or a matched placebo. Participants will come for a Screening Visit, a First Dose Visit, Research Visit One (including MRI scan) and Research Visit Two (including measures of emotional processing and non-emotion cognition).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly allocated to one of three groups (PF-04995264, citalopram or placebo) and receive their allocated study medication for 7 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Depression, Unipolar
Intervention  ICMJE
  • Drug: PF-04995274
    PF-04995274 tablets
  • Drug: Citalopram
    Citalopram capsule
    Other Name: Celexa, Cipramil
  • Drug: Placebo Oral Tablet
    Placebo tablet, identical to PF-04995274 tablet
  • Drug: Placebo oral capsule
    Placebo capsule, identical to citalopram capsule
Study Arms  ICMJE
  • Experimental: PF-04995274

    PF-04995274, three x 5mg tablet (15mg total), once daily for 7-9 days

    + 1 placebo capsule, once daily for 7-9 days

    Interventions:
    • Drug: PF-04995274
    • Drug: Placebo oral capsule
  • Active Comparator: Citalopram

    Citalopram, one x 20mg capsule, once daily for 7-9 days

    + 3 placebo tablets, once daily for 7-9 days

    Interventions:
    • Drug: Citalopram
    • Drug: Placebo Oral Tablet
  • Placebo Comparator: Placebo
    3 placebo tablets and 1 placebo capsule, once daily for 7-9 days
    Interventions:
    • Drug: Placebo Oral Tablet
    • Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
  • Meet DSM-V criteria for current Major Depressive Disorder [as determined by the Structured Clinical interview for DSM-V (SCID)];
  • Participant must have received no drug or face-to-face psychological treatment for the current episode of depression/ in the previous six weeks;
  • 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, female participants must not breastfeed, 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;
  • Current usage of psychotropic medication;
  • Failure to respond to antidepressant medication in current episode;
  • 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; blackouts requiring hospitalisation);
  • Medical conditions that may alter the hemodynamic parameters underlying the BOLD signal (e.g., inadequately treated hypertension, diabetes mellitus);
  • Clinically significant risk of suicide;
  • Current pregnancy (as determined by urine pregnancy test taken during Screening and First Dose Visits), breastfeeding or planning a pregnancy during the course of the study;
  • Participant not willing to use a suitable method of contraception for 30 days after receiving study drug treatment;
  • Any contraindication to MRI scanning (e.g. metal objects in body, pacemakers, significant claustrophobia, pregnancy);
  • Participants with Body Mass Index (BMI) outside the 18 to 36 kg/m2 range at the Screening Visit.
  • Night-shift working or recent travel involving significant change of timezones;
  • Excessive caffeine consumption, i.e., consumption higher than 8 cups of standard caffeinated drinks (tea, instant coffee) or higher than 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day;
  • Participation in a psychological or medical study involving the use of medication within the last 3 months;
  • Previous participation in a study using the same, or similar, emotional processing tasks;
  • Smoker > 10 cigarettes per day or similar levels of tobacco consumption in other forms.
  • Participant received prescribed medication within 28 days prior to Visit 2 (apart from the contraceptive pill). Participants who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety;
  • Participant received non-prescription medication, including supplements such as vitamins and herbal supplements within 48 hours prior to Visit 2 (apart from paracetamol). Participants who have taken non-prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety;
  • Participant with a known hypersensitivity to PF-04995274, citalopram or any other serotonergic agents;
  • Participant with planned medical treatment within the study period that might interfere with the study procedures;
  • Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03516604
Other Study ID Numbers  ICMJE PF04995274 Study 1 RESTAND
MR/P012604/1 ( Other Grant/Funding Number: MRC (UK) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE
  • Medical Research Council
  • Pfizer
Investigators  ICMJE
Principal Investigator:Catherine HarmerUniversity of Oxford
PRS Account University of Oxford
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP