Neuroimaging Predictors of Antidepressant Treatment Outcome

Depression Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02000726
• Other study ID #: HUM00073082
• Status: Withdrawn
• Phase: Phase 2
• First received: October 24, 2013
• Last updated: November 18, 2016
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• Placebo

• Citalopram

• 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.

Locations

Country	Name	City	State
United States	Department of Psychiatry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	BDNF Val66Met single nucleotide polymorphism(SNP)genotyping	5ml of blood drawn per participants will be used for genotyping	At baseline	No
Primary	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	No
Secondary	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.	No