Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression

NCT00655057 | Completed Phase 2 Results DMC

• 2 other identifiers: R34MH070753DATR A3-NSS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.

Conditions

Depression

Keywords

Dopamine Transporter; Biomarker; SPECT Brain Imaging; Antidepressant Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Dopamine Transporter Binding

  Measured at Weeks 0 and 12

Study Arms (3)

1

ACTIVE COMPARATOR

Healthy participants will undergo TRODAT-1 SPECT imaging.

Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imaging

2

EXPERIMENTAL

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.

Drug: S-citalopram; Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imaging

3

ACTIVE COMPARATOR

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.

Behavioral: Cognitive behavioral therapy (CBT); Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imaging

Interventions

S-citalopram DRUG

Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.

2

Cognitive behavioral therapy (CBT) BEHAVIORAL

Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.

3

TRODAT-1 single photon emission computed tomographic (SPECT) imaging PROCEDURE

Participants' striatal dopamine transporter (DAT) levels will be measured using \[99mTc\]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV diagnosis of major depressive episode (MDE) or major depressive disorder (MDD)
• Drug free of psychotropic medication for more than 6 months before study entry
• item Hamilton Depression Scale (HAM-D17) score of greater than 16
• Woman of childbearing age with a negative pregnancy test within 48 hours of study entry
• Absence of DSM-IV Axis I diagnosis as determined by Structured Clinical Interview for DSM Disorders (SCID)

You may not qualify if:

• DSM-IV Axis I diagnosis other than MDE
• History of mania
• Current alcohol or drug abuse, or alcohol or drug dependence within 6 months before study entry
• History of sensitivity or intolerance to s-citalopram
• Medical contraindication to the use of s-citalopram
• Unstable medical condition (e.g., angina pectoris, untreated hypertension)
• Pregnant or breastfeeding
• Woman of childbearing potential not using a medically acceptable form of birth control
• Actively suicidal or requiring hospitalization
• Requiring additional psychotropic drug therapy
• History of transient ischemic attacks
• History of cerebral infarction (including lacunar infarct with symptoms that last more than 24 hours)
• History of Binswanger's disease (or a history of hypertensive encephalopathy)
• History of intracranial hemorrhage
• History of head trauma with loss of consciousness

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Depression Research Unit - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Dexetimide; Cognitive Behavioral Therapy; X-Rays

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Limitations and Caveats

Data is unavailable for the following reasons: Principal Investigator has succumb to serious health issues preventing data input, and study team is no longer with the university and is unreachable to input data.

Results Point of Contact

• Title: Tyrone Quarterman
• Organization: University of Pennsylvania

tyroneq@upenn.edu

215-349-5537

Study Officials

• Jay D. Amsterdam, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 9, 2008
• Study Start: October 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 16, 2020
• Results First Posted: April 16, 2020

Record last verified: 2020-04

Locations

US (1)