This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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This study has been withdrawn prior to enrollment.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: November 18, 2016
Last verified: November 2016
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
Depression 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 (Participant)

Resource links provided by NLM:

Further study details as provided by Marta Pecina Iturbe, 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 ]

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. ]

Other Outcome Measures:
  • Neuropsychological functioning of patients with depression [ Time Frame: At baseline ]

    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 ]
    5ml of blood drawn per participants will be used for genotyping

Enrollment: 0
Study Start Date: July 2013
Study Completion Date: June 2014
Primary Completion Date: June 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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 18, 2016

Additional relevant MeSH terms:
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on August 18, 2017