Brain Imaging of Quetiapine Response in Anxious Depression

NCT00982345 | Completed Phase 4 Results

• 1 other identifier: 0901-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out what parts of the brain have increased or decreased connectivity when people are depressed and how Seroquel extended release (XR) changes this connectivity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain.

Conditions

Major Depression

Keywords

Depression; Anxiety; Seroquel; Quetiapine; fMRI; pictures

Outcome Measures

Primary Outcomes (1)

• 17-item Hamilton Depression Rating Scale (HDRS)

  Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.

  Started: March 2009 Ending March 2011

Study Arms (1)

Open label Quetiapine

OTHER

Open-label Quetiapine XL 50 - 400 mg daily treatment 8 weeks

Drug: quetiapine (Seroquel XR)

Interventions

quetiapine (Seroquel XR) DRUG

Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.

Also known as: Seroquel XR

Open label Quetiapine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written informed consent
• A diagnosis of Major Depressive Episode by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
• Females or Males aged 18 - 60 years
• Female subjects of childbearing potential must be using a reliable method of contraception and have a negative serum human chorionic gonadotropin (HCG) test at enrollment
• Able to understand and comply with the requirements of the study
• item Hamilton Depression Rating Scale (HDRS) score \> 15
• Hamilton Anxiety Scale (HAM-A) score \> 15
• Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire
• Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:
• Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
• No danger to self or others.

You may not qualify if:

• Pregnancy or lactation
• Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder
• Subjects who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
• Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within four weeks prior to enrollment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (angina pectoris, hypertension) as judged by the investigator
• Involvement in the planning and conduct of the study
• Previous enrollment or randomization of treatment in the present study.
• Participation in another drug trial within four weeks prior enrollment into this study or longer in accordance with local requirements
• A subject with Diabetes Mellitus; people who develop hyperglycemia will be removed from the study

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• AstraZeneca: collaborator

Study Sites (1)

Indiana University Adult Psychiatry Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Anxiety Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Open label study. Small sample

Results Point of Contact

• Title: Dr. Amit Anand
• Organization: Indiana University

aanand@iupui.edu

317-274-7422

Study Officials

• Amit Anand, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 23, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 30, 2016
• Results First Posted: September 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)