Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression

NCT00641108 | Completed Phase 2 Results DMC

• 2 other identifiers: R34MH077580DATR A5-ETMA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine changes in brain serotonin activity in people with depression before and after they receive cognitive behavioral therapy.

Conditions

Depression

Keywords

SPECT Brain Imaging; Cognitive Therapy; Serotonin Transporter Binding; Predictive Biomarker

Outcome Measures

Primary Outcomes (1)

• Change in Serotonin Transporter Availability

  Measured at Weeks 0 and 12

Study Arms (2)

ADAM SPECT

EXPERIMENTAL

Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.

Drug: ADAM SPECT plus Cognitive Therapy

Control

ACTIVE COMPARATOR

Healthy subjects without depression will undergo ADAM SPECT scans.

Drug: ADAM SPECT plus No Therapy

Interventions

ADAM SPECT plus Cognitive Therapy DRUG

ADAM SPECT

ADAM SPECT plus No Therapy DRUG

Control

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 disorder (MDD)
• Drug naive from prior psychotropic medication for more than 6 months before study entry
• Hamilton-Depression (HAM-D) 17 score greater than or equal to 16
• Woman of childbearing age with a negative pregnancy test within 48 hours of scanning

You may not qualify if:

• DSM-IV Axis I diagnosis other than MDD
• Use of psychotropic medication within 6 months of study entry
• History of bipolar disorder
• Current alcohol or drug abuse/dependence within 6 months of 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 nursing
• 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 more than 24 hours in duration)
• History of Binswanger's disease or a history of hypertensive encephalopathy
• History of intracranial hemorrhage

Sponsors & Collaborators

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

Study Sites (1)

Depression Research Unit - University of Pennsylvania

Philadelphia, Pennsylvania, 19104-3309, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Data is unavailable due to the following extenuating circumstances: principal investigator has serious health complications preventing him from inputting data, and study team has left 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

• Robert J. DeRubeis, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 21, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 16, 2020
• Results First Posted: April 16, 2020

Record last verified: 2020-04

Locations

US (1)