Trials Sponsors Conditions Drugs Pricing

Conditions

Depression Depressive Disorder, Major Depressive Disorder Unipolar Depression Major Depressive Disorder

Keywords

ExercisePhysical activityGABAVenlafaxinefMRISpectroscopyReward systemBDNFSleepCognitive functionBiomarkersAerobic exercise

Outcome Measures

Primary Outcomes (1)

Number of Participants Experiencing Remission
Study completers will be classified as remitters vs. non-remitters. Remission will be defined as a MADRS score of 10 or less for at least two consecutive assessments. The MADRS will also be used to assess clinical response throughout the trial and to determine final medication dosage. At the end of week 6, those with a MADRS score greater than 10 will have the venlafaxine XR increased from 150 mg/d to a maximum of 300 mg/d.
Baseline, weekly for weeks 1 and 2, then biweekly for weeks 4-12

Secondary Outcomes (6)

Inflammatory Biomarkers
Baseline and 12 weeks
Genetic Biomarkers
Baseline and 12 weeks

Study Arms (2)

Aerobic Exercise + Venlafaxine XR

EXPERIMENTAL

Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks. Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. Heart rate will be closely monitored during sessions. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention. Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).

Drug: Venlafaxine XROther: Aerobic ExerciseDrug: Lorazepam

Venlafaxine XR Only

ACTIVE COMPARATOR

Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks. Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).

Interventions

Venlafaxine XRDrug

Also known as: Effexor XR

Aerobic Exercise + Venlafaxine XRVenlafaxine XR Only

Aerobic ExerciseOther

Also known as: Physical Activity, Cardiovascular Exercise

Eligibility Criteria

Age60 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ages 20-39 (recruitment complete) and 60-79 years old (open to recruitment)
Major depressive disorder (MDD), single or recurrent, as diagnosed by the PRIME-MD

Sponsors & Collaborators

Kirk Erickson, PhD
Otherlead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Related Publications (25)

Butters MA, Young JB, Lopez O, Aizenstein HJ, Mulsant BH, Reynolds CF 3rd, DeKosky ST, Becker JT. Pathways linking late-life depression to persistent cognitive impairment and dementia. Dialogues Clin Neurosci. 2008;10(3):345-57. doi: 10.31887/DCNS.2008.10.3/mabutters.
PMID: 18979948BACKGROUND
Kohler S, Thomas AJ, Barnett NA, O'Brien JT. The pattern and course of cognitive impairment in late-life depression. Psychol Med. 2010 Apr;40(4):591-602. doi: 10.1017/S0033291709990833. Epub 2009 Aug 6.
PMID: 19656429BACKGROUND

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorDepressive DisorderMotor Activity

Interventions

Venlafaxine HydrochlorideExerciseLorazepam

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanols

Results Point of Contact

Title: Dr. Kirk Erickson
Organization: University of Pittsburgh

Study Officials

Kirk Erickson, PhD
University of Pittsburgh
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

31 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Associate Professor/Principal Investigator

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 3, 2015

Study Start

March 2015

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Inability to provide informed consent.
Modified Mini-Mental Score (3MS) less than 84 or dementia based upon Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria including poor performance on the clinical neuropsychological battery, IQCODE, and all available clinical information.
Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
Abuse of or dependence on alcohol or other substances within the past three months
High risk for suicide \[e.g., active suicidal ideation (SI) and/or current/recent intent or plan\] AND unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). Urgent psychiatric referral will be made in these cases.
Contraindication to venlafaxine XR as determined by study physician including history of intolerance of venlafaxine XR in the study target dosage range (venlafaxine XR at up to 300 mg/day).
Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English).
Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
Unstable/uncontrolled medical illness, including delirium, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
Subjects taking psychotropic medications that cannot be safely tapered or discontinued prior to study initiation
If a patient failed a trial of venlafaxine (12 weeks of treatment with venlafaxine including at least 6 weeks on 300mg/day), he/she would not be eligible.
Other drugs that may affect the GABA system will be excluded (e.g., Kava, Valerian, Theanine, and GABA supplements).
The drug Linezolid (Zyvox) should be discontinued prior to study enrollment and should not be used during the study.
Current medical condition or treatment for a medical condition that could affect balance, gait, or contraindicate participation in moderate intensity physical activity.
Observed gait condition or use of walking assisted device that would contraindicate use of treadmill for exercise testing and intervention.
+4 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Aerobic Exercise + Venlafaxine XR

Venlafaxine XR Only

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (25)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations