Desipramine for Improving Cellular Signaling and Decreasing Symptoms of Major Depression

Depression Clinical Trial

Official title:

Psychopharmacology of Biogenic Amines in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320632
• Other study ID #: R01MH015413
• Secondary ID: R01MH015413
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2006
• Last updated: August 17, 2015
• Start date: August 1990
• Est. completion date: July 1993

Study information

• Verified date: August 2015
• Source: Harvard Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 1993
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Desipramine

Locations

Country	Name	City	State
United States	Massachusetts Mental Health Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Medical School	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured at Weeks 1, 4, and 6: Catecholamine metabolism and blood cell adenylate cyclase activity
Primary	Score on the 21-item Hamilton Depression Rating Scale