Desipramine for Improving Cellular Signaling and Decreasing Symptoms of Major Depression

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00320632
First received: April 28, 2006
Last updated: May 8, 2006
Last verified: April 2006
  Purpose

This study will determine the effectiveness of desipramine in improving cellular signaling, and thereby decreasing symptoms of depression in people with major depressive disorder (MDD).


Condition Intervention Phase
Depression
Drug: Desipramine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychopharmacology of Biogenic Amines in Depression

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Measured at Weeks 1, 4, and 6: Catecholamine metabolism and blood cell adenylate cyclase activity
  • Score on the 21-item Hamilton Depression Rating Scale

Estimated Enrollment: 43
Study Start Date: August 1990
Estimated Study Completion Date: July 1993
Detailed Description:

MDD is a serious mental illness that can interfere with a person’s ability to eat, sleep, work, and enjoy activities that were once pleasurable. It is characterized by several symptoms, including as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. The receptor-G protein-adenylate cyclase enzyme complex (AC enzyme complex) is a major cell signaling system in the brain, blood, and other tissues in the body. Changes in this signaling system among blood cells have been observed in people with major depressive disorder. Research has shown that treatment with the benzodiazepine alprazolam corrects the signaling problem, and thereby improves symptoms of MDD. This study will determine whether impairments in the AC enzyme complex exist among depressed individuals. This study will also evaluate the effectiveness of desipramine, an antidepressant, in improving blood cell signaling, and thereby decreasing symptoms of depression in people with major depressive disorder.

Both healthy and depressed participants will be recruited for this study. All depressed participants in this study will first be assessed for depression severity using the Hamilton Depression Rating Scale. If eligible for the study, participants will be examined to determine AC enzyme complex functioning in both platelets and mononuclear leukocytes. A cohort of the depressed participants will be treated with desipramine. They will be examined to determine the drug’s effect on AC enzyme complex functioning, as well as its effect on MDD symptoms, at Weeks 1, 4, and 6.

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of MDD (as defined by SCID [DSM III-R] and a score of at least 15 on the 21-item Hamilton Depression Scale)
  • Able to swallow tablets, give urine and blood samples, and participate in periodic evaluations during the study
  • Healthy volunteers show no current Axis I or Axis II disorders and score less than 8 on the Hamilton Depression Scale

Exclusion Criteria:

  • Use of any of the following medications within the 2 weeks prior to study entry: psychoactive medication; aspirin; or nonsteroidal anti-inflammatory agents
  • Any alcohol or drug abuse within the 6 months prior to study entry
  • Any major medical disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320632

Locations
United States, Massachusetts
Massachusetts Mental Health Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph J. Schildkraut, MD Department of Psychiatry, Harvard Medical School
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00320632     History of Changes
Other Study ID Numbers: R01 MH15413
Study First Received: April 28, 2006
Last Updated: May 8, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Major Depressive Disorder
MDD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Desipramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014