Health TrialsbyHealthPanel

Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

ConditionsSchizophreniaSchizo Affective Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVishwajit Nimgaonkar, MD PhD

About this trial

This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent.

Both genders, ages 18-60 years

Schizophrenia / schizoaffective disorder (DSM V).

Treated with the same APD for at least 60 days; Stable dose of APD for > 1 month, continued throughout the study.

Disqualifiers

No illicit substance use in last 30 days/no dependence in 6 months with the exception of methadone treatment for opioid withdrawal.

History or current medical /neurological illnesses that may lead to an unstable course with the exception of epilepsy which is well-controlled on an antiepileptic medication for at least 6 months.

Pregnancy.

History of immune disorders, HIV infection, or receiving immune-suppressants or immuno-modulators, e.g., steroids.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cromoglycate

    Drug

    Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray

  • Placebo

    Drug

    Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: CromoglycateActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Improvement in positive symptoms

Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)

Time frame
12 weeks

Secondary outcomes

1

Total Symptoms

Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 30 Items, (minimum score = 7, maximum score = 210)

Time frame
12 weeks
2

Negative Symptoms

Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)

Time frame
12 weeks
3

Cognition

As measured by the Penn Computerized Neurocognitive Battery (CNB)

Time frame
12 weeks
4

Sheehan's disability scale (SDS)

The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired)

Time frame
12 Weeks

Other outcomes

1

Total Positive and Negative Syndrome Scale (PANSS)

Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 30 Items, (minimum score = 7, maximum score = 210)

Time frame
12 weeks
2

Penn Computerized Neurocognitive Battery (CNB)

Developed in the Brain Behavior Lab at Penn, the CNB is a series of computerized tests that measure accuracy and speed of performance in major domains of cognition, including social-cognition. Battery measures the executive functions of abstraction and mental flexibility, attention, and working memory, episodic memory for words, faces and figures, intellectual functioning including verbal and nonverbal reasoning and spatial orientation, facial emotion processing and sensorimotor and motor speed. The participant completes this test on the computer with oversight by a research team member.

Time frame
12 weeks
3

Sheehan's disability scale (SDS)

The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired)

Time frame
12 weeks
4

Global Assessment of Function (GAF)

The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100.

Time frame
12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vishwajit Nimgaonkar, MD PhD

Lead sponsor

University of Pittsburgh

Sponsor institution

Stanley Medical Research Institute

Collaborator

Source ClinicalTrials.gov
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