Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms

NCT00955474 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2008P001022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and tolerability of Seroquel monotherapy for the treatment of Major Depression with Psychotic features with Seroquel plus Selective Serotonin Reuptake Inhibitor.

Conditions

Major Depressive Disorder With Psychotic Features

Outcome Measures

Primary Outcomes (2)

• Depression

  Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe.

  8 weeks

• Psychosis

  Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe.

  8 weeks

Secondary Outcomes (13)

• Fasting Blood Glucose

  8 weeks

• CPFQ (Cognitive and Psychological Functioning Questionnaire)

  8 weeks

• RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score

  8

• RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score

  8 weeks

• RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.

  8 weeks

Study Arms (2)

Quetiapine

EXPERIMENTAL

Patients assigned to receive Quetiapine

Drug: Quetiapine

Quetiapine and SSRI

ACTIVE COMPARATOR

Patients assigned to receive Quetiapine and SSRI

Drug: Quetiapine; Drug: escitalopram; Drug: Sertraline; Drug: Citalopram

Interventions

Quetiapine DRUG

Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Also known as: Quetiapine (generic name): Seroquel (brand name)

Quetiapine; Quetiapine and SSRI

escitalopram DRUG

Active comparator arm: Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.

Also known as: Lexapro

Quetiapine and SSRI

Sertraline DRUG

Active comparator arm: Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m. Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m. Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.

Also known as: Zoloft (brand name)

Quetiapine and SSRI

Citalopram DRUG

Active comparator arm: Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.

Also known as: Celexa

Quetiapine and SSRI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Diagnosis of Major Depressive Disorder with Psychotic Features by the DSM-IV
• Females and Males between the ages of 18-85 years.
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
• Able to understand and comply with the requirements of the study
• Initial HAM-D-17 score of \> 16, both at the screen visit and at the baseline visit.
• Participants must have an initial BPRS score of \> 25 and at least one of the following: \> 5 for item 1, \> 5 for item 5, \> 5 for item 8, \> 4 for item 9, \> 1 for item 10, \> 1 for item 11; these BPRS criteria msut be met both at the screen visit and at the baseline visit.
• Participants must have an initial CGI score of \> 2, both at the screen visit and at the baseline visit.

You may not qualify if:

• Pregnancy or lactation
• Patients 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 enrollment 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 randomization
• Substance or alcohol dependence within the past three months (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 4 weeks prior to enrolment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
• Involvement in the planning and conduct of the study
• Previous enrolment or randomization of treatment in the present study.
• Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
• A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
• Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) \> 8.5%.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Quetiapine Fumarate; Escitalopram; Sertraline; Citalopram

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: John D. Matthews, MD
• Organization: Massachusetts General Hospital

jdmatthews@partners.org

6177249144

Study Officials

• John D Matthews, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Inpatient Research & Training

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 10, 2009
• Study Start: September 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 20, 2017
• Results First Posted: March 28, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)