Neural Responses and Dysphoria: Modulation by a Pharmacological Probe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101685
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : June 7, 2011
P1vital Limited
University of Manchester
Institute of Psychiatry, London
Information provided by:
University of Oxford

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Dysphoria Drug: Escitalopram Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Escitalopram
7 days dosing at 10mg per day
Drug: Escitalopram
7 days dosing of 10mg per day

Placebo Comparator: Placebo
7 days dosing at 10mg daily
Drug: Placebo
7 days dosing at 10mg daily

Primary Outcome Measures :
  1. Blood Oxygen Level Dependent (BOLD) responses during emotional and cognitive processing [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Validating the sensitivity of dysphoric verses nondysphoric reactions to cognitive and emotional stimuli in detecting antidepressant drug effects. [ Time Frame: 1 day ]

    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

  2. Genetic influences on the processing of cognitive and emotional stimuli. [ Time Frame: 6 months to 1 year after study completion ]
  3. Relationship between BOLD fMRI signals and emotional processing using a biomarker test battery [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01101685

United Kingdom
Department of Psychiatry
Oxford, United Kingdom, OX3 7JX
Sponsors and Collaborators
University of Oxford
P1vital Limited
University of Manchester
Institute of Psychiatry, London
Principal Investigator: Guy Goodwin University of Oxford

Responsible Party: Professor Guy Goodwin, Oxford University, Department of Psychiatry Identifier: NCT01101685     History of Changes
Other Study ID Numbers: P1V-DEP-CT02-09
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: June 2011

Keywords provided by University of Oxford:

Additional relevant MeSH terms:
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents