Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain

Schizophrenia Clinical Trial

Official title:

Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain: a Placebo-controlled Study in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915938
• Other study ID #: 15-0019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical trial that intend to determine the effects of S-ketamine on event-related potentials associated with semantic affective pain-processing

Description:

Ketamine is a unique anesthetic with neural effects that are distinct from more commonly-used γ-aminobutyric acid agonists. Evidence suggest that analgesic effect of ketamine is primarily related to the affective than the sensorial aspects of pain interpretation. The investigators investigated whether ketamine, a noncompetitive NMDA antagonist, would modify the perceived emotional valence of pain-related words when compared to non-pain-related ones in healthy volunteers. Using a single session double-blind parallel placebo-controlled design, 24 healthy volunteers were randomized to receive intravenous S-ketamine (n=12) or placebo (n=12). During infusion (plasmatic target of 60 ng/ml), the effects of ketamine were recorded using EEG and oddball behavioral data was monitored. Evoked potentials (N200 and P300 components) were recorded during performance of a semantic written word oddball task containing pain-related (targets) and non-pain-related words (standards). Expected results: The findings of this study can help in the understanding of neurophysiologic mechanisms involved in ketamine's effects both in psychiatric diseases as in the treatment of postoperative acute and chronic pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• male healthy subjects with higher education level

Exclusion Criteria:

• do not understand Portuguese language

• obese patients (BMI > 27 kg/m2)

• use of NSAID, steroids, analgesics, anticonvulsant drugs, as well as alpha and beta-blockers

• score = 13 on Beck II Questionnaire

• sleep deprivation in the night before evaluation

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Chronic Pain, Widespread
• Schizophrenia

Intervention

Drug:
• Ketamine
S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml
• Placebo
Administered in an identical way than ketamine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective euphoria rating	Euphoria will be rated using an analogue visual scale ranging of 0 to 10.	up to 60 min
Other	Subjective sedation rating	Sedation will be rated using an analogue visual scale ranging of 0 (completely awake) to 100 (sleeping).	up to 60 min
Primary	AUC of the grand averaged mean differences between ERPs elicited by target and non-target words	EEG will be recorded during all task time. The main outcome will be the area under de curve (AUC) of the grand averaged mean differences between event-related potencials (ERPs) elicited by target and non-target words at 100-200, 300-500 and 800-900 ms after stimulus presentation for parietal electrophysiological signal (Pz). The ERPs represent the averaged voltage of several trials.	up to 60 min
Secondary	Word ratings related to the semantic valence	After viewing each word, volunteers were asked to classify them according to the semantic valence in the following categories: "positive," "negative" or "neutral."	up to 60 min
Secondary	Response times (behavioural oddball data)	Response times to word classification in oddball task	up to 60 min