DysphoriaPhase 4NCT01101685
Neural Responses and Dysphoria: Modulation by a Pharmacological Probe
A Phase 4 study testing Escitalopram in people with Dysphoria, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study aims to improve understanding of how people with low mood and negative feelings (known as dysphoric) may be different from people with normal mood and feelings (nondysphoric) when responding to a variety of social and emotional information. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphoria
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 45 years, inclusive at Randomisation visit.
- Fluent English speakers.
- Beck Depression Inventory (BDI) score of 05 or ≥10 at both Screening and Randomisation visits.
- Hamilton Depression Rating Scale (HAMD)score of <24 at both Screening and Randomisation visits.
- Healthy at Screening visit as determined by a physician.
- Female participants should be surgically sterile or abstinent or, if sexually active, be practising an effective method of birth control.
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- Acceptable weight as defined by body mass index (BMI) range of 18 to 30 kg/m², inclusive.
- Normotensive with sitting (5 minutes) blood pressure between the range of 100 to 140 mmHg systolic, inclusive and 60 to 90 mmHg diastolic, inclusive at Screening.
- Non smoker or light smoker (≤ 5 cigarettes per day).
- Participants must have signed the Informed Consent Form.
- Participants providing a genetic sample must have signed the DNA consent.
Who cannot join
- History of alcohol or substance dependence within the last 6 months.
- Consumption of large amounts of caffeinated drinks.
- Relevant history or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (diabetes),cancer, blood disease, gastrointestinal, hepatic or renal disease or other condition.
- History or presence of significant neurological or psychiatric conditions. Exceptions to this are participants with a history of depression for the dysphoric group. Participants with generalised anxiety disorder or other anxiety disorders may be entered at the discretion of the Investigator.
- Participants who, in the opinion of the Investigator, are at risk of suicide.
- Any use of sedative hypnotics, including benzodiazepines, zolpidem or zopiclone within the last 3 months prior to Randomisation visit.
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- Any use of medications for depression in the last three months prior to Randomisation visit.
- Have received prescribed medication within 14 days prior to Randomisation visit (apart from the contraceptive pill).
- Have received over-the-counter (OTC) medicine within 48 hours prior to Randomisation visit.
- Have received an experimental drug and/or used an experimental medical device within 30 days of Randomisation visit or within a period less than 5 times the drug's half life, whichever is longer.
- If female: are pregnant or are trying to get pregnant or are currently breast feeding.
- History of, or current condition of, migraine headaches or have undergone operations to the head.
- Significant hearing impairment.
- Significant visual impairment or history of ocular treatment.
- Lefthanded.
- Previous experience of the emotional test battery experimental procedures.
- Unable to comply with magnetic resonance (MR) Patient Declaration.
- Involvement in an emergency (medically emergent) situation between Screening and Randomisation visits.
- Surgery between Screening and Randomisation visits.
- Unable or unwilling to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Oxygen Level Dependent (BOLD) Responses During Emotional and Cognitive Processing in Dysphoric and Non-dysphoric Participants and Their Modulation by a Pharmacological Probe of Serotonin Function
This study aims to improve understanding of how people with low mood and negative feelings (known as dysphoric) may be different from people with normal mood and feelings (nondysphoric) when responding to a variety of social and emotional information. The study will look at the patterns of activity in peoples' brains in situations (presented as a battery of tests) after treatment with a medicine (escitalopram) or a placebo. The results from this study will help to gather information about the effectiveness of the various tests being used in this study in detecting any changes due to treatment with an antidepressant. Half the volunteers taking part in this study will be dysphoric (mildly depressed) whilst the other half of volunteers will be healthy volunteers. It is hoped that the results of this study will provide guidance for assessing effectiveness of new medicines and potentially help with the treatment of depression.
- Conditions
- Dysphoria
- Being tested
- Escitalopram, Placebo
- Keywords
- non-dysphoric, Dysphoric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
7 days dosing of 10mg per day
PlaceboDrug
7 days dosing at 10mg daily
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Active comparator | 7 days dosing at 10mg per day Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | 7 days dosing at 10mg daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) responses during emotional and cognitive processing
Measured: 1 day
Secondary outcomes (3)
Validating the sensitivity of dysphoric verses nondysphoric reactions to cognitive and emotional stimuli in detecting antidepressant drug effects.
Using tests of cognitive and emotional processing, specially:
Emotional Counting Stroop Emotional Encoding Task Sad Music Visual checkerboard Facial Expression Processing Dot-Probe N-Back digit Symbol substitution California Verbal Learning Test Depression Realism Task
Measured: 1 day
Genetic influences on the processing of cognitive and emotional stimuli.
Measured: 6 months to 1 year after study completion
Relationship between BOLD fMRI signals and emotional processing using a biomarker test battery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoriaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- P1vital Limited, University of Manchester, Institute of Psychiatry, London
- Investigators
- Guy Goodwin, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101685
- Sponsor's protocol ID
- P1V-DEP-CT02-09
- Status last verified
- Jun 2011
- First submitted
- 31 Mar 2010
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Oxygen Level Dependent (BOLD) Responses During Emotional and Cognitive Processing in Dysphoric and Non-dysphoric Participants and Their Modulation by a Pharmacological Probe of Serotonin Function
- ClinicalTrials.gov ID
- NCT01101685
- Acronym / sponsor ID
- P1V-DEP-CT02-09
- Conditions
- Dysphoria
- Keywords
- non-dysphoric, Dysphoric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- P1vital Limited, University of Manchester, Institute of Psychiatry, London
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to improve understanding of how people with low mood and negative feelings (known as dysphoric) may be different from people with normal mood and feelings (nondysphoric) when responding to a variety of social and emotional information. The study will look at the patterns of activity in peoples' brains in situations (presented as a battery of tests) after treatment with a medicine (escitalopram) or a placebo. The results from this study will help to gather information about the effectiveness of the various tests being used in this study in detecting any changes due to treatment with an antidepressant. Half the volunteers taking part in this study will be dysphoric (mildly depressed) whilst the other half of volunteers will be healthy volunteers. It is hoped that the results of this study will provide guidance for assessing effectiveness of new medicines and potentially help with the treatment of depression.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Active comparator | Drug: Escitalopram7 days dosing at 10mg per day |
| Placebo | Placebo comparator | Drug: Placebo7 days dosing at 10mg daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female aged 18 to 45 years, inclusive at Randomisation visit.
- Fluent English speakers.
- Beck Depression Inventory (BDI) score of 05 or ≥10 at both Screening and Randomisation visits.
- Hamilton Depression Rating Scale (HAMD)score of <24 at both Screening and Randomisation visits.
- Healthy at Screening visit as determined by a physician.
Key exclusion criteria (20 listed)
- History of alcohol or substance dependence within the last 6 months.
- Consumption of large amounts of caffeinated drinks.
- Relevant history or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (diabetes),cancer, blood disease, gastrointestinal, hepatic or renal disease or other condition.
- History or presence of significant neurological or psychiatric conditions. Exceptions to this are participants with a history of depression for the dysphoric group. Participants with generalised anxiety disorder or other anxiety disorders may be entered at the discretion of the Investigator.
- Participants who, in the opinion of the Investigator, are at risk of suicide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram7 days dosing of 10mg per day | Drug | Escitalopram |
| Placebo7 days dosing at 10mg daily | Drug | Placebo |
Primary outcome
Blood Oxygen Level Dependent (BOLD) responses during emotional and cognitive processing
Time frame: 1 day
3 secondary outcomes
Validating the sensitivity of dysphoric verses nondysphoric reactions to cognitive and emotional stimuli in detecting antidepressant drug effects.
Time frame: 1 day
Genetic influences on the processing of cognitive and emotional stimuli.
Time frame: 6 months to 1 year after study completion
Relationship between BOLD fMRI signals and emotional processing using a biomarker test battery
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Goodwin principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Dysphoria, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level Dependent (BOLD) responses during emotional and cognitive processing (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2011; AzTrials last refreshed its copy on 5 Nov 2026.