Neural Responses and Dysphoria: Modulation by a Pharmacological Probe

This study has been completed.
Sponsor:
Collaborators:
P1vital Limited
University of Manchester
Institute of Psychiatry, London
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01101685
First received: March 31, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Dysphoria
Drug: Escitalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Blood Oxygen Level Dependent (BOLD) responses during emotional and cognitive processing [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validating the sensitivity of dysphoric verses nondysphoric reactions to cognitive and emotional stimuli in detecting antidepressant drug effects. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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


  • Genetic influences on the processing of cognitive and emotional stimuli. [ Time Frame: 6 months to 1 year after study completion ] [ Designated as safety issue: No ]
  • Relationship between BOLD fMRI signals and emotional processing using a biomarker test battery [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101685

Locations
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
Investigators
Principal Investigator: Guy Goodwin Oxford University
  More Information

No publications provided

Responsible Party: Professor Guy Goodwin, Oxford University, Department of Psychiatry
ClinicalTrials.gov Identifier: NCT01101685     History of Changes
Other Study ID Numbers: P1V-DEP-CT02-09
Study First Received: March 31, 2010
Last Updated: June 6, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
non-dysphoric
Dysphoric

Additional relevant MeSH terms:
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014