Neurotrophic Factors and Depression (Lex/BDNF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00812994
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : December 22, 2008
Information provided by:
University of California, San Francisco

Brief Summary:
Study intended to determine if there are baseline differences in serum neurosteroid levels and neurotrophic factor (BDNF) levels in healthy controls vs unmedicated depressed subjects, and whether the levels of these change with antidepressant treatment. Study also intended to determine if baseline neurosteroid/ BDNF levels, and the change in these levels with =treatment, are correlated with clinical antidepressant response to escitalopram (Lexapro).

Condition or disease Intervention/treatment Phase
Depression Drug: Escitalopram Drug: Placebo Phase 4

Detailed Description:
The study was approved by the UCSF Committee on Human Research, and all participants gave informed consent. The depressed subjects began treatment with placebo for one week, followed by escitalopram for eight weeks (10 mg per day x 4 weeks, followed by 20 mg per day x 4 weeks, as tolerated) in a double-blind, fixed-order, within-subject cross-over manner. The depressed subjects and the psychiatric rater were unaware of the study design and the sequence and duration of treatments. Depressed and control subjects underwent venipuncture to obtain blood for assays. The controls underwent venipuncture once, and the depressed subjects had venipuncture just prior to beginning active escitalopram treatment and again after 8 weeks of escitalopram treatment. Blood was also collected at Weeks 4 and 8 of treatment in the depressed subjects for assay of citalopram and citalopram metabolites, to gauge medication compliance. Finally, depression severity and global clinical change were assessed in the depressed subjects at Baseline and at the end of Week 8 of escitalopram treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Blood Levels of Neurosteroids and Neurotrophic Factors in Normal Controls and in Patients With Major Depression
Study Start Date : January 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: Escitalopram Drug: Escitalopram
SSRI antidepressant
Other Name: Lexapro

Primary Outcome Measures :
  1. Serum BDNF levels [ Time Frame: Baseline, week 4, week 8 ]
  2. Serum allopregnanolone levels [ Time Frame: Baseline, week 4, week 8 ]

Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale [ Time Frame: baseline, week 4, week 8 ]
  2. Clinical Global Impression [ Time Frame: Baseline, week 4, week 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Male subjects with unipolar Major Depressive Disorder (DSM-IV) with a minimum score of 22 on the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS) who were medication-free for at least 6 weeks, were enrolled. Fifteen individually age-matched (+ 3 years) healthy male controls with no history of psychiatric illness were also enrolled. Subjects' ages ranged from 22- 55 y.o. (mean + S.D.= 41.4 + 8.75 y.o.). All subjects were required to pass a urine toxicology screen (assessing the presence of drugs of abuse) on the day of testing.

Exclusion Criteria:

Individuals with co-morbid panic disorder were excluded, since they may poorly tolerate typical starting doses of antidepressants , and individuals with co-morbid post-traumatic stress disorder were excluded, since they may have neuroendocrine regulatory responses different from those of depressed subjects without PTSD. Exclusion criteria for both groups included recent (within 6 months) alcohol or drug abuse as defined by DSM-IV criteria, concurrent psychotherapeutic interventions, poor medical health or abnormal clinical labs, active suicidality, and use of medications that could interfere with the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812994

United States, California
University of California San Francisco
San Francisco, California, United States, 94143-0984
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Owen M Wolkowitz, MD University of California, San Francisco

Responsible Party: Owen Wolkowitz, UCSF Identifier: NCT00812994     History of Changes
Other Study ID Numbers: H3097-19671-08
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: December 22, 2008
Last Verified: December 2008

Keywords provided by University of California, San Francisco:
neurotrophic factor

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents