Neuroimaging Predictors of Antidepressant Treatment Outcome

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).

Study Overview

• Status: Withdrawn
• Conditions: Depression
• Intervention / Treatment: Drug: Placebo; Drug: Citalopram; Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria will include Hamilton Depressive Rating Scale (HDRS) scores >15 and Snaith-Hamilton Pleasure Scale scores (SHAPS) > 7.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo and Citalopram; 4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day	Drug: Placebo; Drug: Citalopram; Other Names: Celexa; Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session; Fast acting antidepressant-like treatment administered intravenously for 35 min. during the fMRI scanning session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychological functioning of patients with depression	Affect processing: Emotional Words Task and Facial Emotion Perception test. Attention and Inhibitory Control: Parametric Go/NoGo, Trail Making test and the Stroop Color Word test . Inferential Reasoning (including cost-benefit analysis): Delayed Discounting of Money Rewards, Iowa Gambling Task, Common Difference effect gambling task and the WCST.	At baseline
BDNF Val66Met single nucleotide polymorphism(SNP)genotyping	5ml of blood drawn per participants will be used for genotyping	At baseline

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 4, 2013

Study Record Updates

• Last Update Posted (Estimate): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 18, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents, Second-Generation; Citalopram; Antidepressive Agents
• Other Study ID Numbers: HUM00073082