SchizophreniaPhase 4RIS-CIT-SCHNCT00893256

Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia

A Phase 4 study testing Risperidone and Citalopram in people with Schizophrenia and Negative Symptoms, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 17 to 50 years
Conditions the study is for: Schizophrenia, Negative Symptoms
What is being tested?: Risperidone and Citalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteIndia
Study dates: Dec 2004to Sep 2007
Phase: Phase 4
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 17 to 50 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Patients fulfilling DSMIV Criteria for Schizophrenia
The patient should be drug naïve or drug free for one month (oral antipsychotic) or three months of parental antipsychotic
Duration from onset < 5 years
Informed consent

Who cannot join

Patient with any other current Axis I or Axis II comorbid disorders
Comorbid substance abuse or dependence except nicotine or caffeine
Presence of significant medical disorder such as epilepsy, uncontrolled hypertension and diabetes mellitus, thyroid disorder
Patient who has not responded to adequate course of risperidone (with reference to dose and duration)
Treatment-resistant schizophrenia defined as non-response to three different antipsychotics belonging to at least two different classes, one of which is an atypical agent and one of which is a depot neuroleptic
Patient who has received ECT in past 3 months

Trial locations and contacts

1 site in 1 country.

India1 site

National Institute of Mental Health and Neurosciences (NIMHANS)
Bangalore, Karnataka, 560 029

Other trials in India

About this study

Official title: Prospective Double-Blind Randomized Comparison Study of Improvement in Negative Symptoms With Risperidone vs Risperidone +Citalopram Combination Therapy in Schizophrenia--a Clinical Study

Negative symptoms in schizophrenia present a challenge to the clinician owing to their poorer response to conventional treatment with antipsychotics. Negative symptoms in schizophrenia may be secondary to psychotic symptoms, depressive symptoms, drug-related side effects or lack of environmental stimulation. Alternately, they may represent core features of the illness, characterized as primary deficit symptoms. Previous studies have suggested that atypical antipsychotics may be beneficial in improving deficit symptoms of schizophrenia. This study aimed at characterizing the nature of improvement of negative symptoms in the early phase (12 weeks) of treatment with the atypical antipsychotic, risperidone. In order to account for factors contributing to improvement in secondary negative symptoms, ratings were carried out of change in positive symptoms, depressive symptoms and drug-related side effects. Further, add-on citalopram or placebo were administered in a double-blind design to study the effect of selective serotonin reuptake inhibitor (SSRI) augmentation of risperidone on negative symptoms. The investigators hypothesized that the improvement in negative symptoms during the initial phase (12 weeks) of treatment with risperidone will be largely accounted for by improvement in secondary negative symptoms, rather than of the primary deficit symptoms.

Conditions: Schizophrenia, Negative Symptoms
Being tested: Risperidone, Citalopram, Placebo
Keywords: schizophrenia, risperidone, citalopram, secondary negative symptoms
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisperidoneDrug
Also called Respidon
Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks
risperidoneDrug
Also called Respidon
Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks
CitalopramDrug
Also called Citopam
Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks
PlaceboDrug
Placebo: once daily

Study groups in NCT00893256
Study group	Role	What they receive
Risperidone and citalopram	Experimental	24 patients were randomized to receive add-on citalopram (20 mg/day) in a double-blind fashion to open-label risperidone (4-8 mg/day) Receives: Drug: Risperidone; Drug: Citalopram
Risperidone and placebo	Placebo comparator	24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day) Receives: Drug: risperidone; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in PANSS negative symptom score
Measured: 12 weeks

Secondary outcomes (1)

Change in PANSS total score
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Sep 2007

First posted5 May 2009 (estimated)
Study startDec 2004
Primary completionSep 2007
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00893256
Sponsor's protocol ID: NFRPA/006/2004
Acronym: RIS-CIT-SCH
Status last verified: May 2009
First submitted: 4 May 2009
Last updated: 5 May 2009
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Double-Blind Randomized Comparison Study of Improvement in Negative Symptoms With Risperidone vs Risperidone +Citalopram Combination Therapy in Schizophrenia--a Clinical Study
ClinicalTrials.gov ID: NCT00893256
Acronym / sponsor ID: RIS-CIT-SCH / NFRPA/006/2004
Conditions: Schizophrenia, Negative Symptoms
Keywords: schizophrenia, risperidone, citalopram, secondary negative symptoms
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
Study start: Dec 2004
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 5 May 2009 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Risperidone and citalopram	Experimental	Drug: Risperidone, Drug: Citalopram24 patients were randomized to receive add-on citalopram (20 mg/day) in a double-blind fashion to open-label risperidone (4-8 mg/day)
Risperidone and placebo	Placebo comparator	Drug: risperidone, Drug: Placebo24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day)

Who may qualify

Ages: 17 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Patients fulfilling DSMIV Criteria for Schizophrenia
The patient should be drug naïve or drug free for one month (oral antipsychotic) or three months of parental antipsychotic
Duration from onset < 5 years
Informed consent

Key exclusion criteria (6 listed)

Patient with any other current Axis I or Axis II comorbid disorders
Comorbid substance abuse or dependence except nicotine or caffeine
Presence of significant medical disorder such as epilepsy, uncontrolled hypertension and diabetes mellitus, thyroid disorder
Patient who has not responded to adequate course of risperidone (with reference to dose and duration)
Treatment-resistant schizophrenia defined as non-response to three different antipsychotics belonging to at least two different classes, one of which is an atypical agent and one of which is a depot neuroleptic

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
RisperidoneAlso: RespidonRisperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks	Drug	Risperidone and citalopram
risperidoneAlso: RespidonRisperidone: tablet; 4-8 mg/day; once daily; 12 weeks	Drug	Risperidone and placebo
CitalopramAlso: CitopamCitalopram: tablet; oral; 20 mg/day; once daily; 12 weeks	Drug	Risperidone and citalopram
PlaceboPlacebo: once daily	Drug	Risperidone and placebo

Primary outcome

Change in PANSS negative symptom score
Time frame: 12 weeks

1 secondary outcome

Change in PANSS total score
Time frame: 12 weeks

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 5 May 2009.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

John P John, M.D. principal investigator

National Institute of Mental Health and Neurosciences, Bangalore, INDIA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risperidone and Citalopram in people with Schizophrenia and Negative Symptoms, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.

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 4 inclusion and 6 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 5 May 2009. 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 India. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Change in PANSS negative symptom score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00893256.

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 5 May 2009.