DepressionPhase 3NCT00197951
Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
A Phase 3 study testing Treatment of psychiatric symptoms associated to alcoholism in people with Depression and Anger, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Alcohol dependent patients show comorbid psychiatric symptoms, related to malfunction of dopamine, norepinephrine and serotonin neurotransmission, during early recovery. Ziprasidone can improve malfunctioning of these disregulated systems, thereby improving anxiety, depression, anhedonia, anger, and alcohol craving. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anger, Anxiety
- What is being tested?
- Treatment of psychiatric symptoms associated to alcoholism
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2004to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV-TR criteria for alcohol dependence disorder
- Age between 18 -65 years old.
- Score 7 or higher in the GHQ-28 scale.
Who cannot join
- More than 30 days without drinking alcohol.
- Severe medical disorders.
- Psychotic or bipolar disorders severely decompensated requiring antipsychotic medication.
- Opiate, cocaine or benzodiazepine dependence disorders, requiring more than one week of detoxification treatment.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
About this study
Official title: Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.
Alcohol dependent patients show comorbid psychiatric symptoms, related to malfunction of dopamine, norepinephrine and serotonin neurotransmission, during early recovery. Ziprasidone can improve malfunctioning of these disregulated systems, thereby improving anxiety, depression, anhedonia, anger, and alcohol craving.
Read the detailed description
60 alcohol-dependent patients will be included, once finished alcohol detoxification treatment.Thirty patients will receive ziprasidone treatment, in progressively increasing doses, starting from 40 mg per day, and the other 30 patients will receive placebo, in a double blind procedure
- Conditions
- Depression, Anger, Anxiety, Alcoholism
- Being tested
- Treatment of psychiatric symptoms associated to alcoholism
- Keywords
- Psychiatric symptoms associated to alcoholism recovery, Alcoholism treatment, Alcohol craving, Relapse to heavy drinking, Abuse of other substances during alcoholism recovery
- Medical subject headings
- Depression, Anxiety Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of psychiatric symptoms associated to alcoholismDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Score opf SCL-90-R psychiatric symptoms scale.
Secondary outcomes (3)
Alcohol consumption (amount and frequency)
Alcohol craving
Other substances consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Josep Guardia, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197951
- Sponsor's protocol ID
- 2004-001056-36
- Other IDs
- 2004
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 23 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.
- ClinicalTrials.gov ID
- NCT00197951
- Acronym / sponsor ID
- 2004-001056-36
- Conditions
- Depression, Anger, Anxiety, Alcoholism
- Keywords
- Psychiatric symptoms associated to alcoholism recovery, Alcoholism treatment, Alcohol craving, Relapse to heavy drinking, Abuse of other substances during alcoholism recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol dependent patients show comorbid psychiatric symptoms, related to malfunction of dopamine, norepinephrine and serotonin neurotransmission, during early recovery. Ziprasidone can improve malfunctioning of these disregulated systems, thereby improving anxiety, depression, anhedonia, anger, and alcohol craving.
Detailed description
60 alcohol-dependent patients will be included, once finished alcohol detoxification treatment.Thirty patients will receive ziprasidone treatment, in progressively increasing doses, starting from 40 mg per day, and the other 30 patients will receive placebo, in a double blind procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV-TR criteria for alcohol dependence disorder
- Age between 18 -65 years old.
- Score 7 or higher in the GHQ-28 scale.
Key exclusion criteria (5 listed)
- More than 30 days without drinking alcohol.
- Severe medical disorders.
- Psychotic or bipolar disorders severely decompensated requiring antipsychotic medication.
- Opiate, cocaine or benzodiazepine dependence disorders, requiring more than one week of detoxification treatment.
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of psychiatric symptoms associated to alcoholism | Drug | – |
Primary outcome
Score opf SCL-90-R psychiatric symptoms scale.
3 secondary outcomes
Alcohol consumption (amount and frequency)
Alcohol craving
Other substances consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Guardia, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment of psychiatric symptoms associated to alcoholism in people with Depression and Anger, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score opf SCL-90-R psychiatric symptoms scale.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2007.