Neurotrophic Factors and Depression (Lex/BDNF)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00812994
First received: December 19, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
Depression
Drug: Escitalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Blood Levels of Neurosteroids and Neurotrophic Factors in Normal Controls and in Patients With Major Depression

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Serum BDNF levels [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Serum allopregnanolone levels [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2003
Study Completion Date: November 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Escitalopram Drug: Escitalopram
SSRI antidepressant
Other Name: Lexapro

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.

  Eligibility

Ages Eligible for Study:   22 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00812994

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

No publications provided

Responsible Party: Owen Wolkowitz, UCSF
ClinicalTrials.gov Identifier: NCT00812994     History of Changes
Other Study ID Numbers: H3097-19671-08
Study First Received: December 19, 2008
Last Updated: December 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Depression
BDNF
neurotrophic factor
neurosetroid
allopregnanolone

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014