Physiologic Monitoring of Antidepressant Treatment Response

This study has been completed.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00792168
First received: November 14, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

Primary: to identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine;

Secondary: to determine if cordance changes early in the course (i.e., prior to improvement in clinical symptoms) of venlafaxine (or another antidepressant if venlafaxine is not clinically indicated for a particular patient) are predictive of later clinical response.


Condition Intervention Phase
Major Depression
Drug: venlafaxine (Effexor)
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiologic Monitoring of Antidepressant Treatment Response

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • quantitative electroencephalography (QEEG) [ Time Frame: 6 QEEG measurements (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical assessment measuresments: Ham-D, MADRS, Ham-A, SCL-90, Beck, LIFE, and CGI) [ Time Frame: 6 study visits: end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: November 1996
Study Completion Date: December 1998
Arms Assigned Interventions
Active Comparator: 1. Venlafaxine Drug: venlafaxine (Effexor)
venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule
Placebo Comparator: 2. Placebo Other: placebo
venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule

Detailed Description:

After a one-week single-blind placebo lead in, subjects will be randomly assigned to either venlafaxine or placebo for 8 weeks. They will undergo 6 QEEG studies (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment), with examiner and self-ratings of mood, anxiety, and clinical status at the time of each recording (Ham-D, MADRS, Ham-A, SCL-90, Beck, LIFE, and CGI) to assess improvement. Any subjects with significant deterioration in mood and/or suicidal ideation during the 8 week trial will be dropped from the study and placed in open treatment.

At the end of 8 weeks, code will be broken and all subjects will be maintained/re-assigned to open-label treatment with venlafaxine for an additional 10 months if they wish. However, if the subject's primary physician believes that another clinically available antidepressant would be indicated instead of venlafaxine (due to history of prior non-response to venlafaxine, etc.), the indicated antidepressant medication will be administered. The antidepressant medication recommended by the primary physician will be provided free of charge for a one-year period. Tricyclic antidepressants and monoamine oxidase inhibitors will not be included due to the greater possibility of serious clinical sequelae with these older medications. The open-label phase will consist of regular monitoring by the laboratory at intervals of three days and one week after beginning a new antidepressant medication, and then monthly clinical visits (or more frequently if clinically indicated) with QEEG recordings and assessments of mood and clinical status as above by the laboratory psychiatrist to ensure that the subject is getting appropriate care from his or her primary physician. Drug dose will be adjusted using standard clinical practice by the subject's primary physician in the community, and if the subject remains on venlafaxine, the dosage may be increased as high as 225 mg/day during this phase.

Subjects will have one additional follow-up QEEG at the end of the open-label phase or when significant clinical improvement is detected (defined as resolution of DSM-IV symptoms, or Ham-D < 9). After the subject's depression resolves, he or she will continue to be monitored and given medication free of charge for the remainder of the one-year period, but will be seen clinically only by the primary physician in the community. A study psychiatrist will be available for consultation in cases of clinical necessity until the primary physician can be contacted. Subjects for whom venlafaxine is not clinically indicated and/or subjects who refuse the placebo portion of the study may be allowed to bypass the placebo-controlled phase and proceed directly to the open-label phase.

  Eligibility

Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects in the placebo controlled phase of the study having a score on the 17-item Ham-D > 18 (with item #1 > 2). Subjects will meet criteria both at recruitment, and after a one-week single blind placebo wash-in. - Study includes outpatients only.

Exclusion Criteria:

  • All subjects will have no serious medical illness.
  • The investigators will exclude patients also meeting criteria for the following groups of axis I diagnoses:

    • delirium or dementia
    • substance-related disorders
    • schizophrenia or other psychotic disorders
    • eating disorders.
  • In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded.
  • Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the placebo-controlled phase of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792168

Locations
United States, California
University of California
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Andrew F Leuchter, MDe UCLA Department of Psychiatry and Biobeavioral Sciences
  More Information

No publications provided

Responsible Party: Andrew Leuchter, M.D., Assoc. Professor, University of California at Los Angeles, Department of Psychiatry and Biobehavioral Sciences
ClinicalTrials.gov Identifier: NCT00792168     History of Changes
Other Study ID Numbers: 96-06-291
Study First Received: November 14, 2008
Last Updated: November 14, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Venlafaxine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 21, 2014