Completed

Sertraline and Cognitive Therapy for Depression and Alcohol Reduction

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What is being tested

sertraline (Zoloft)

+ cognitive behavior therapy

DrugBehavioral
Who is being recruted

Behavior+5

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

The study focuses on individuals battling both depression and alcoholism. It aims to find out if a combination of a medication called sertraline (Zoloft) and cognitive behavior therapy can help improve depression symptoms and reduce alcohol consumption. This research is important as it could potentially offer a more effective treatment approach for those dealing with these co-occurring conditions, ultimately improving their quality of life. In this 12-week study, participants are randomly assigned to one of two groups. One group receives sertraline (Zoloft) and cognitive behavior therapy, while the other group receives a placebo (a pill with no active ingredients) and the same therapy. Neither the participants nor the researchers know who is receiving the medication or the placebo. The study is double-blind, meaning it ensures unbiased results. After the treatment period, there are follow-up assessments at 1 and 3 months to evaluate the effectiveness of the treatment. The study measures the participants' progress based on improvements in depression symptoms and reduction in alcohol consumption.

Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismDepression

Criteria

6 inclusion criteria required to participate
Able to maintain sobriety for ten days

Able to read and understand questionnaires and informed consent

Has had no more than one previous inpatient medical detoxification

Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting

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12 exclusion criteria prevent from participating
Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study

Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion

Current charges pending for violent crime (excluding DUI related offenses)

Current homicidal or suicidal ideation

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical University of South Carolina

Charleston, United StatesOpen Medical University of South Carolina in Google Maps
CompletedOne Study Center