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Desipramine for Improving Cellular Signaling and Decreasing Symptoms of Major Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Desipramine
Sponsored by
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major Depressive Disorder, MDD

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts Mental Health Center

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
April 28, 2006
Last Updated
August 17, 2015
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00320632
Brief Title
Desipramine for Improving Cellular Signaling and Decreasing Symptoms of Major Depression
Official Title
Psychopharmacology of Biogenic Amines in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1993 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depressive Disorder, MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Desipramine
Primary Outcome Measure Information:
Title
Measured at Weeks 1, 4, and 6: Catecholamine metabolism and blood cell adenylate cyclase activity
Title
Score on the 21-item Hamilton Depression Rating Scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J. Schildkraut, MD
Organizational Affiliation
Department of Psychiatry, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Mental Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2833319
Citation
Mooney JJ, Schatzberg AF, Cole JO, Kizuka PP, Salomon M, Lerbinger J, Pappalardo KM, Gerson B, Schildkraut JJ. Rapid antidepressant response to alprazolam in depressed patients with high catecholamine output and heterologous desensitization of platelet adenylate cyclase. Biol Psychiatry. 1988 Mar 15;23(6):543-59. doi: 10.1016/0006-3223(88)90002-9.
Results Reference
background
PubMed Identifier
9564442
Citation
Mooney JJ, Samson JA, McHale NL, Colodzin R, Alpert J, Koutsos M, Schildkraut JJ. Signal transduction by platelet adenylate cyclase: alterations in depressed patients may reflect impairment in the coordinated integration of cellular signals (coincidence detection). Biol Psychiatry. 1998 Apr 15;43(8):574-83. doi: 10.1016/s0006-3223(97)00327-2.
Results Reference
background
PubMed Identifier
17727882
Citation
Mooney JJ, Samson JA, Hennen J, Pappalardo K, McHale N, Alpert J, Koutsos M, Schildkraut JJ. Enhanced norepinephrine output during long-term desipramine treatment: a possible role for the extraneuronal monoamine transporter (SLC22A3). J Psychiatr Res. 2008 Jul;42(8):605-11. doi: 10.1016/j.jpsychires.2007.07.009. Epub 2007 Aug 28.
Results Reference
derived

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Desipramine for Improving Cellular Signaling and Decreasing Symptoms of Major Depression

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