Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment

NCT00456014 | Completed Results

• 3 other identifiers: #6351R (formerly 5206)R01MH074813DATR A3-NSS
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use pre-treatment positron emission topography and functional magnetic resonance imaging scans of the brain to predict the most effective antidepressant treatment for people with major depressive disorder.

Conditions

Depression

Keywords

Major Depression; Antidepressants

Outcome Measures

Primary Outcomes (1)

• Remission of Depressive Symptoms

  Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score \<10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.

  Measured at Week 8

Secondary Outcomes (2)

• Remission of Depressive Symptoms - Tricyclic Phase

  Measured over 8 weeks

• Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase

  Measured at Week 8

Study Arms (1)

1 - SSRI

EXPERIMENTAL

Participants will receive standardized pharmacotherapy with the SSRI escitalopram over 8 weeks. Non-remitters after 8 weeks will be offered standardized pharmacotherapy with desipramine

Drug: Escitalopram; Drug: Desipramine

Interventions

Escitalopram DRUG

Escitalopram will be administered at a dose of 10 mg daily for 4 weeks. If participants have not achieved response (greater than 50 % improvement in Hamilton Depression Rating Scale) by 4 weeks, the dose will be increased to 20 mg. Remission status is determined after an 8-week trial.

Also known as: Lexapro

1 - SSRI

Desipramine DRUG

Subsequent to escitalopram trial, non-remitters will be offered pharmacotherapy with desipramine. Desipramine will be initiated at a dose of 50 mg and titrated according to a treatment manual, with monitoring of therapeutic blood levels. Remission status is determined after an 8-week trial.

Also known as: Norpramin

1 - SSRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of current major depressive disorder
• Currently depressed
• Subjects must be generally healthy with no significant medical problems, anemia/blood loss, or cardiac abnormalities
• Likely to tolerate medication washout
• Capacity to provide informed consent
• Off of anti-coagulant/anti-platelet treatment for 10 days
• Willing to travel to Brookhaven for PET scanning

You may not qualify if:

• Current abuse of or dependence on alcohol or another substance (\>6 months remission okay)
• History of other major psychiatric disorders such as bipolar, schizophrenia, schizoaffective; anorexia or bulimia in past year
• First degree family history of schizophrenia if subject is under 33
• Unable/unwilling to discontinue all psychotropic medication that affects the serotonin system
• Pregnant, breastfeeding, or planning to become pregnant during the study
• A medical contraindication to antidepressants
• Dementia
• Prior head trauma with evidence of cognitive impairment
• Well-documented failure of two or more SSRI AND tricyclic antidepressant (TCA) trials of adequate dose and duration
• Metal implants, pacemaker, metal protheses or orthodontic appliance, the presence of shrapnel
• Current past, present, or anticipated exposure to radiation
• Actively suicidal
• Lifetime history of glaucoma
• Lack of response to \>2 trials of antidepressant monotherapy of adequate dose and duration
• Claustrophobia

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Miller JM, Hesselgrave N, Ogden RT, Zanderigo F, Oquendo MA, Mann JJ, Parsey RV. Brain serotonin 1A receptor binding as a predictor of treatment outcome in major depressive disorder. Biol Psychiatry. 2013 Nov 15;74(10):760-7. doi: 10.1016/j.biopsych.2013.03.021. Epub 2013 May 9.

  PMID: 23664414 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Escitalopram; Desipramine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

small sample size, homogeneity of sample size

Results Point of Contact

• Title: Ramin V. Parsey, MD, PhD
• Organization: Stony Brook University School of Medicine

Ramin.Parsey@stonybrookmedicine.edu

631-444-3084

Study Officials

• Ramin V. Parsey, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Jeffrey M Miller, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of clinical psychiatry

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 4, 2007
• Study Start: September 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 19, 2019
• Results First Posted: June 14, 2017

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)