Neuroimaging Predictors of Antidepressant Treatment Outcome

Phase 2

Withdrawn

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

• Registration Number: NCT02000726
• Lead Sponsor: University of Michigan

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo and Citalopram	Placebo	4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day
Placebo and Citalopram	Citalopram	4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day
Placebo and Citalopram	Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session	4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Psychiatry; 🇺🇸 Ann Arbor, Michigan, United States