Study of the Effects of an Antidepressant Medication and Placebo on the Brain Functioning of Normal Subjects
Condition: Depression
MeSH terms: Depression
Intervention: venlafaxine
Intervention description: venlafaxine IR 150mg
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are assigned to one of two groups (antidepressant-experienced and antidepressant-naive) and receive parallel treatment (1 week of placebo followed by 4 weeks of venlafaxine) for the duration of the study. Subjects and assessors were blinded to treatment condition.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: We compared EEG outcomes for those subjects who had been randomly assigned to blinded treatment with venlafaxine (antidepressant-experienced, n=2) vs. placebo (antidepressant-naive, n=4). All subjects received 1 week of placebo followed by 4 weeks of venlafaxine. Subjects were blinded to the treatment during both phases of the study using lookalike capsules. Outcomes assessors and the treating physician also were blinded to treatment condition.
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study examines the effects of an antidepressant medication and placebo on the brain
      functioning of normal subjects. In this study, recordings of brain electrical activity are
      being used to detect and monitor the response to treatment with venlafaxine IR (Effexor), a
      drug used for the treatment of depression. The intent of this study is to test specific
      hypotheses regarding:

        1. long-term brain effects of a single course of antidepressant treatment

        2. pharmaco-conditioning effects underlying antidepressant tolerance/sensitization

        3. brain functional response to initial versus subsequent antidepressant trials in normal
           healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject age is 18-75 years

          -  Subject must be in overall good health (i.e., free of any medical condition known to
             affect brain function).

          -  Subject must have participated in former study, Physiologic Monitoring of
             Antidepressant Medication Effects in Normal Controls Subjects (IRB#: 00-11-038-13)

          -  Subject has had a normal physical exam within one year prior to entry of the study

          -  Capacity to give Informed Consent

        Exclusion Criteria:

          -  Subject has serious medical illness, such as high blood pressure, heart disease, renal
             impairment, or cirrhosis of the liver.

          -  Subject meets DSM-IV Axis I criteria for a mood, anxiety, cognitive, or psychiatric
             disorder; or meets criteria for cluster A or B axis II diagnoses. These disorders will
             be determined on the basis of a structured assessment with the MINI (Mini
             International Neuropsychiatric Interview for DSM-IV Axis I Disorders)

          -  Subject has a history of current or past active suicidal ideation or suicide attempts.

          -  Subject has received treatment with an antidepressant medication or any medications
             that could influence brain function since his/her participation in the initial study

          -  Subject is using any of the following medications which interfere with EEG measures of
             brain function: Anticholinergics, Barbiturates, Benzodiazepines, Sedating
             Antihistamines (e.g. diphenhydramine (Benadryl) would be exclusionary, but not
             loratadine (Claritin))

          -  Subject has a history of seizures, brain surgery, skull fracture, significant head
             trauma, or previous abnormal EEG

          -  Subject is pregnant or planning on becoming pregnancy during course of the study

          -  Subject is a UCLA student or staff member directly under instruction or employment of
             any of the investigators