DHEA EFFECTS ON MOOD IN DEPRESSED HIV+ PATIENTS

Summary

Principal Investigator: J G Rabkin
Abstract: This is a double blind, placebo-controlled clinical trial of the antidepressant effect of DHEA among HIV+ individuals. Secondary goals will include determination of whether DHEA has anabolic effects or androgenic effects on enrolled subjects. The investigators will consider the basic endocrinology of adrenal steroid metabolism in the subjects, and propose to assess the effects of DHEA on immune status and viral activity with regard to the safety of the use of DHEA in HIV infected individuals. The study is an eight week double blind controlled trial of oral DHEA vs. placebo with an eight week maintenance phase for drug responders, and 16 weeks of open treatment offered to placebo non-responders (after the eight week double blind trial). They propose a 1:1 randomization and predict that 114 enrolled individuals will complete the eight week trial. If DHEA ameliorates depressive symptoms, as well as increasing libido and reducing loss of muscle mass, then the investigators will have identified an intervention with a broad spectrum of action suitable for both men and women with HIV infection, that is practical, inexpensive, and accessible. With regard to the endocrine studies, the investigators will assess precursors and metabolites of DHEA before and after oral administration of the compound, and examine effects of cortisol, triglycerides, insulin, cholesterol, growth hormone, IGF-1, and IGF-1 binding proteins. Tests will be administered at study baseline, weeks 4 and 8, including standard dose ACTH, low dose ACTH, CRF, and GNRH stimulation tests to assess the hypothalamic-pituitary-adrenal and hypothalamic-pituitary gonadal function before and after DHEA administration. This will permit the investigators to assess potential underlying mechanisms for the putative therapeutic effects of DHEA on mood, libido, and body composition.
Funding Period: 2000-08-10 - 2005-07-31
more information: NIH RePORT

Top Publications

  1. ncbi The diagnosis of adrenal insufficiency in a patient with Allgrove syndrome and a novel mutation in the ALADIN gene
    Marzieh Salehi
    Department of Medicine, Division of Endocrinology and Metabolism, Beth Israel Medical Center, Albert Einstein College of Medicine, New York, NY 10003, USA
    Metabolism 54:200-5. 2005
  2. ncbi Direct thiazolidinedione action in the human ovary: insulin-independent and insulin-sensitizing effects on steroidogenesis and insulin-like growth factor binding protein-1 production
    Donna Seto-Young
    Division of Endocrinology, Beth Israel Medical Center, 317 East 17th Street, Fierman Hall, Seventh Floor, New York, New York 10003, USA
    J Clin Endocrinol Metab 90:6099-105. 2005
  3. ncbi Hormonally active nontransformed human ovarian cell culture from oophorectomy specimens: methods of development and initial characterization
    Donna Seto-Young
    Division of Endocrinology, Department of Medicine, Beth Israel Medical Center and Albert Einstein College of Medicine, NY 10003, USA
    Horm Res 64:238-47. 2005
  4. ncbi Placebo-controlled trial of dehydroepiandrosterone (DHEA) for treatment of nonmajor depression in patients with HIV/AIDS
    Judith G Rabkin
    New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA
    Am J Psychiatry 163:59-66. 2006
  5. ncbi Endocrine effects of oral dehydroepiandrosterone in men with HIV infection: a prospective, randomized, double-blind, placebo-controlled trial
    Leonid Poretsky
    Division of Endocrinology, Department of Medicine, Weill Medical College of Cornell University, The New York Presbyterian Hospital, New York, NY 10021, USA
    Metabolism 55:858-70. 2006
  6. pmc Metabolic and hormonal effects of oral DHEA in premenopausal women with HIV infection: a randomized, prospective, placebo-controlled pilot study
    L Poretsky
    Division of Endocrinology, Department of Medicine, Weill Medical College of Cornell University, The New York Presbyterian Hospital, New York, USA
    Horm Metab Res 41:244-9. 2009

Scientific Experts

  • L Poretsky
  • J G Rabkin
  • Donna Seto-Young
  • Marzieh Salehi
  • Peter Chang
  • Alice Park
  • Kevin Holcomb
  • Maria Paliou
  • Olga Leonardi
  • Zev Rosenwaks
  • Jonathan Schlosser
  • Dimiter Avtanski
  • Arsalan Sheikh
  • Parini Patel
  • Melissa Yih
  • Henry Houlden

Detail Information

Publications6

  1. ncbi The diagnosis of adrenal insufficiency in a patient with Allgrove syndrome and a novel mutation in the ALADIN gene
    Marzieh Salehi
    Department of Medicine, Division of Endocrinology and Metabolism, Beth Israel Medical Center, Albert Einstein College of Medicine, New York, NY 10003, USA
    Metabolism 54:200-5. 2005
    ....
  2. ncbi Direct thiazolidinedione action in the human ovary: insulin-independent and insulin-sensitizing effects on steroidogenesis and insulin-like growth factor binding protein-1 production
    Donna Seto-Young
    Division of Endocrinology, Beth Israel Medical Center, 317 East 17th Street, Fierman Hall, Seventh Floor, New York, New York 10003, USA
    J Clin Endocrinol Metab 90:6099-105. 2005
    ..Direct effects of TZDs in the ovary, however, cannot be excluded. We explored direct effects of TZDs in cultured human ovarian cells...
  3. ncbi Hormonally active nontransformed human ovarian cell culture from oophorectomy specimens: methods of development and initial characterization
    Donna Seto-Young
    Division of Endocrinology, Department of Medicine, Beth Israel Medical Center and Albert Einstein College of Medicine, NY 10003, USA
    Horm Res 64:238-47. 2005
    ....
  4. ncbi Placebo-controlled trial of dehydroepiandrosterone (DHEA) for treatment of nonmajor depression in patients with HIV/AIDS
    Judith G Rabkin
    New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA
    Am J Psychiatry 163:59-66. 2006
    ..Subsyndromal major depressive disorder is common among HIV-positive adults. This study was designed to assess the efficacy of dehydroepiandrosterone (DHEA) as a potential treatment...
  5. ncbi Endocrine effects of oral dehydroepiandrosterone in men with HIV infection: a prospective, randomized, double-blind, placebo-controlled trial
    Leonid Poretsky
    Division of Endocrinology, Department of Medicine, Weill Medical College of Cornell University, The New York Presbyterian Hospital, New York, NY 10021, USA
    Metabolism 55:858-70. 2006
    ..Long-term studies are needed to assess the clinical significance of these hormonal changes in subjects with HIV infection receiving oral DHEA therapy...
  6. pmc Metabolic and hormonal effects of oral DHEA in premenopausal women with HIV infection: a randomized, prospective, placebo-controlled pilot study
    L Poretsky
    Division of Endocrinology, Department of Medicine, Weill Medical College of Cornell University, The New York Presbyterian Hospital, New York, USA
    Horm Metab Res 41:244-9. 2009
    ..Long-term studies with larger groups of patients are needed to confirm these data and to determine their clinical significance...