Trial Outcomes & Findings for Study of the Effects of an Antidepressant Medication and Placebo on the Brain Functioning of Normal Subjects (NCT NCT00634283)

Results Overview

Cordance values were calculated from conventional 'absolute' and 'relative' qEEG power measures using a three-step procedure. First, EEG power values were computed using a re-attributional electrode montage. Second, the absolute and relative power values were z-transformed to measure deviation from the mean values for each electrode site s in each frequency band f for that recording, yielding Anorm(s,f) and Rnorm(s,f), respectively. Third, these z-scores were summed to yield a cordance "intensity" value, Z, for each electrode in each frequency band where Z(s,f) = Anorm(s,f) + Rnorm(s,f). Analyses for this report focused on changes-from-baseline theta-band (8-12Hz) cordance in the prefrontal region (electrodes Fp1, Fpz, Fp2). Results are defined in terms of positive and negative change where a positive change represents an increased physiologic and behavioral response to the drug (sensitization) and a negative change represents an increased tolerance to the drug (habituation).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

Average over 4 weeks

Results posted on

2020-03-09

Participant Flow

All 142 research subjects were enrolled at the Laboratory of Brain, Behavior and Pharmacology from 8/19/05-9/30/08.

Subjects were required to wash out from any exclusionary medication for at least two weeks. Subjects taking fluoxetine were required to wash out for at least 30 days prior to treatment assignment.

Participant milestones

Participant milestones
Measure	Venlafaxine IR (Effexor) Five weeks of treatment with venlafaxine IR
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Effects of an Antidepressant Medication and Placebo on the Brain Functioning of Normal Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Venlafaxine IR (Effexor) n=6 Participants Five weeks of treatment with venlafaxine IR
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46.5 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Average over 4 weeks

Population: Antidepressant-experienced subjects; n=2 and antidepressant-naive subjects; n=4

Cordance values were calculated from conventional 'absolute' and 'relative' qEEG power measures using a three-step procedure. First, EEG power values were computed using a re-attributional electrode montage. Second, the absolute and relative power values were z-transformed to measure deviation from the mean values for each electrode site s in each frequency band f for that recording, yielding Anorm(s,f) and Rnorm(s,f), respectively. Third, these z-scores were summed to yield a cordance "intensity" value, Z, for each electrode in each frequency band where Z(s,f) = Anorm(s,f) + Rnorm(s,f). Analyses for this report focused on changes-from-baseline theta-band (8-12Hz) cordance in the prefrontal region (electrodes Fp1, Fpz, Fp2). Results are defined in terms of positive and negative change where a positive change represents an increased physiologic and behavioral response to the drug (sensitization) and a negative change represents an increased tolerance to the drug (habituation).

Outcome measures

Outcome measures
Measure	Antidepressant Treatment-experienced n=2 Participants Subjects in this group had prior exposures to antidepressant medication (venlafaxine)	Antidepressant Treatment-naive n=4 Participants Subjects in this group had never before been exposed to antidepressant medication
Changes in Quantitative Electroencephalogram (qEEG) Prefrontal Cordance (PFC) Over Time (4 Weeks). PFC at Baseline	-0.09 z-score Standard Deviation 0.86	-0.88 z-score Standard Deviation 1.55
Changes in Quantitative Electroencephalogram (qEEG) Prefrontal Cordance (PFC) Over Time (4 Weeks). PFC change after placebo lead-in	-0.54 z-score Standard Deviation 0.44	-0.09 z-score Standard Deviation 0.46

PRIMARY outcome

Timeframe: 1-week placebo lead-in

Cordance values were calculated from conventional 'absolute' and 'relative' qEEG power measures using a three-step procedure. First, EEG power values were computed using a re-attributional electrode montage. Second, the absolute and relative power values were z-transformed to measure deviation from the mean values for each electrode site s in each frequency band f for that recording, yielding Anorm(s,f) and Rnorm(s,f), respectively. Third, these z-scores were summed to yield a cordance "intensity" value, Z, for each electrode in each frequency band where Z(s,f) = Anorm(s,f) + Rnorm(s,f). Analyses for this report focused on changes-from-baseline theta-band (8-12Hz) cordance in the prefrontal region (electrodes Fp1, Fpz, Fp2). Results are defined in terms of positive and negative change where a positive change represents an increased physiologic and behavioral response to the drug (sensitization) and a negative change represents an increased tolerance to the drug (habituation).

Outcome measures

Outcome measures
Measure	Antidepressant Treatment-experienced n=2 Participants Subjects in this group had prior exposures to antidepressant medication (venlafaxine)	Antidepressant Treatment-naive n=4 Participants Subjects in this group had never before been exposed to antidepressant medication
Changes in Quantitative Electroencephalogram (qEEG) Prefrontal Cordance (PFC) Over 1 Week Placebo lead-in.	-0.54 Z-score Standard Deviation 0.44	-0.09 Z-score Standard Deviation 0.46

Adverse Events

Antidepressant Treatment-experienced

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Antidepressant Treatment-naive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of the Laboratory of Brain

Laboratory of Brain, Behavior, and Pharmacology at UCLA

Phone: 310-825-0207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place