Neuroimaging Predictors of Antidepressant Treatment Outcome

NCT02000726 | Withdrawn Phase 2

• 1 other identifier: HUM00073082
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Current medical therapies for depression take weeks to achieve full efficacy, and are ineffective in many patients or cause intolerable side effects, emphasizing the need for a deeper understanding of depression and its treatment. Identifying early brain biomarkers of treatments responses seems necessary to improve antidepressant treatment outcome. In this study we aim to detect early brain responses to a fast acting antidepressant-like treatment administered intravenously during a Real-Time Neurofeedback functional magnetic resonance imaging (MRI) Task to predict antidepressant treatment outcome in depression. At completion of the neuroimaging task, participants will enter a placebo-controlled clinical trial with a selective serotonin reuptake inhibitor (SSRI).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Blood-oxygen-level dependent (BOLD) responses during the Real-Time Neurofeedback Task.

  BOLD responses will be assessed at baseline and depression severity will be assessed at baseline

Secondary Outcomes (1)

• Depression severity assessed with several depressive questionnaires.

  Every two weeks until the end of the trial (16 weeks total), or until the participants leave the study.

Other Outcomes (2)

• Neuropsychological functioning of patients with depression

  At baseline

• BDNF Val66Met single nucleotide polymorphism(SNP)genotyping

  At baseline

Study Arms (1)

Placebo and Citalopram

EXPERIMENTAL

4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day

Drug: Placebo; Drug: Citalopram; Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session

Interventions

Placebo DRUG

Placebo and Citalopram

Citalopram DRUG

Also known as: Celexa

Placebo and Citalopram

Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session DRUG

Fast acting antidepressant-like treatment administered intravenously for 35 min. during the fMRI scanning session.

Placebo and Citalopram

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• suicidal ideation, comorbid conditions that are medical, neurological or psychiatric, pregnancy, use of hormones (including birth control) or use of psychotropic agents. We will only permit certain past anxiety disorder diagnoses, including generalized anxiety, panic, agoraphobia, social phobia.
• We will also exclude left-handed individuals and patients who have used any centrally acting medications, nicotine, or recreational drugs within the past 2 months.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Department of Psychiatry

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: December 4, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

US (1)