Neural Responses and Dysphoria: Modulation by a Pharmacological Probe

NCT01101685 | Completed Phase 4

• 1 other identifier: P1V-DEP-CT02-09
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphoria

Keywords

non-dysphoric; Dysphoric

Outcome Measures

Primary Outcomes (1)

• Blood Oxygen Level Dependent (BOLD) responses during emotional and cognitive processing

  1 day

Secondary Outcomes (3)

• Validating the sensitivity of dysphoric verses nondysphoric reactions to cognitive and emotional stimuli in detecting antidepressant drug effects.

  1 day

• Genetic influences on the processing of cognitive and emotional stimuli.

  6 months to 1 year after study completion

• Relationship between BOLD fMRI signals and emotional processing using a biomarker test battery

  1 day

Study Arms (2)

Escitalopram

ACTIVE COMPARATOR

7 days dosing at 10mg per day

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

7 days dosing at 10mg daily

Drug: Placebo

Interventions

Escitalopram DRUG

7 days dosing of 10mg per day

Escitalopram

Placebo DRUG

7 days dosing at 10mg daily

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• P1vital Limited: collaborator
• University of Manchester: collaborator
• Institute of Psychiatry, London: collaborator

Study Sites (1)

Department of Psychiatry

Oxford, OX3 7JX, United Kingdom

Location

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Guy Goodwin

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 12, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

GB (1)