Neuroimaging Predictors of Antidepressant Treatment Outcome

This study has been withdrawn prior to enrollment.
(Lack of funding to complete the trial phase of the study.)
Information provided by (Responsible Party):
Marta Pecina Iturbe, University of Michigan Identifier:
First received: October 24, 2013
Last updated: December 1, 2014
Last verified: December 2014
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).

Condition Intervention Phase
Drug: Placebo
Drug: Citalopram
Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Blood-oxygen-level dependent (BOLD) responses during the Real-Time Neurofeedback Task. [ Time Frame: BOLD responses will be assessed at baseline and depression severity will be assessed at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression severity assessed with several depressive questionnaires. [ Time Frame: Every two weeks until the end of the trial (16 weeks total), or until the participants leave the study. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Neuropsychological functioning of patients with depression [ Time Frame: At baseline ] [ Designated as safety issue: No ]

    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.

  • BDNF Val66Met single nucleotide polymorphism(SNP)genotyping [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    5ml of blood drawn per participants will be used for genotyping

Enrollment: 0
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT02000726

United States, Michigan
Department of Psychiatry
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Marta Pecina Iturbe, MD PhD, University of Michigan Identifier: NCT02000726     History of Changes
Other Study ID Numbers: HUM00073082 
Study First Received: October 24, 2013
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antidepressive Agents
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors processed this record on May 26, 2016