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PharmacofMRI of Anxiolytic Medications (Pregabalin)

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ClinicalTrials.gov Identifier: NCT00706836
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : December 22, 2014
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Condition Anxiety Disorders
Interventions Drug: Pregabalin 50mg
Drug: Pregabalin 200 MG
Drug: placebo
Enrollment 16
Recruitment Details Healthy subjects recruited by posted advertisements.
Pre-assignment Details Subjects determined to be healthy based on physical examination, mental health examination, and routine bloodwork.
Arm/Group Title All Study Participants
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Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo

All participants received all 3 treatments on different days.

Sequence not available.

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title All 3 Treatments (Cross-Over Design)
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Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo

All subjects received all 3 treatments on different days.

Sequence data not available.

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
16 healthy subjects (10 male; mean age=23.2±2.6)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
23.2  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
6
  37.5%
Male
10
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Effect of Pregabalin (Two Doses) Versus Placebo
Hide Description Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.
Time Frame Week 1, 2, 3 (Cross-over Design)
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Hide Analysis Population Description
Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order.
Arm/Group Title Pregabalin Low Dose (Crossover) Pregabalin High Dose (Crossover) Placebo (Crossover)
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Pregabalin oral tablets (50 mg)

pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan

Pregabalin oral tablets (200 mg)

pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan

Placebo

placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan

Overall Number of Participants Analyzed 16 16 16
Mean (Standard Error)
Unit of Measure: % signal change L amygdala + anticipn
0.6  (0.2) -0.1  (0.1) 0.6  (0.2)
Time Frame Acute within 2 hours of administration
Adverse Event Reporting Description Single dose acute adverse events
 
Arm/Group Title Pregabalin Low Dose (Crossover) Pregabalin High Dose (Crossover) Placebo (Crossover)
Hide Arm/Group Description

Pregabalin oral tablets (50 mg)

pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan

Pregabalin oral tablets (200 mg)

pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan

Placebo

placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan

All-Cause Mortality
Pregabalin Low Dose (Crossover) Pregabalin High Dose (Crossover) Placebo (Crossover)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Low Dose (Crossover) Pregabalin High Dose (Crossover) Placebo (Crossover)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin Low Dose (Crossover) Pregabalin High Dose (Crossover) Placebo (Crossover)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      4/16 (25.00%)      0/16 (0.00%)    
Nervous system disorders       
Dizziness * [1]  0/16 (0.00%)  0 4/16 (25.00%)  4 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Dizziness or lightheadedness
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Murray B. Stein MD, MPH
Organization: University of California San Diego
Phone: 858-534-6400
Responsible Party: Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00706836     History of Changes
Other Study ID Numbers: UCSD IRB 060407 - B
R01MH075792 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2008
First Posted: June 30, 2008
Results First Submitted: December 3, 2014
Results First Posted: December 22, 2014
Last Update Posted: April 9, 2019